Trial Outcomes & Findings for Early ART to Limit Infection and Establishment of Reservoir (NCT NCT02859558)
NCT ID: NCT02859558
Last Updated: 2025-08-29
Results Overview
Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction \[qPCR\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
At week 48
Results posted on
2025-08-29
Participant Flow
Participants were enrolled from January 2017 to December 2019 at 30 sites in Brazil, Malawi, Peru, Thailand, United States, and Zimbabwe.
There was no randomization in this study. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1. Confirmed Fiebig VI and HIV negative participants were replaced.
Participant milestones
| Measure |
Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 2: Fiebig III/IV
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Fiebig VI
Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
HIV-negative
Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
|
|---|---|---|---|---|---|
|
Step 1
STARTED
|
49
|
79
|
60
|
4
|
3
|
|
Step 1
Completed Week 48
|
41
|
68
|
50
|
0
|
0
|
|
Step 1
COMPLETED
|
37
|
67
|
49
|
4
|
0
|
|
Step 1
NOT COMPLETED
|
12
|
12
|
11
|
0
|
3
|
|
Step 2
STARTED
|
26
|
42
|
23
|
0
|
0
|
|
Step 2
COMPLETED
|
22
|
37
|
19
|
0
|
0
|
|
Step 2
NOT COMPLETED
|
4
|
5
|
4
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 2: Fiebig III/IV
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Fiebig VI
Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
HIV-negative
Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
|
|---|---|---|---|---|---|
|
Step 1
Not Eligible
|
0
|
0
|
0
|
0
|
3
|
|
Step 1
Lost to Follow-up
|
1
|
3
|
3
|
0
|
0
|
|
Step 1
Did Not Return to Clinic
|
2
|
3
|
4
|
0
|
0
|
|
Step 1
Moved
|
0
|
1
|
1
|
0
|
0
|
|
Step 1
Withdrawal By Participant
|
1
|
2
|
1
|
0
|
0
|
|
Step 1
Had to Interrupt antiretroviral (ARV)
|
1
|
0
|
0
|
0
|
0
|
|
Step 1
Incarceration
|
0
|
1
|
0
|
0
|
0
|
|
Step 1
Non-Adherence to Study Drug
|
2
|
0
|
1
|
0
|
0
|
|
Step 1
Non-Adherence to Study Requirements
|
3
|
1
|
0
|
0
|
0
|
|
Step 1
Virologic Failure
|
2
|
1
|
1
|
0
|
0
|
|
Step 2
Lost to Follow-up
|
3
|
3
|
1
|
0
|
0
|
|
Step 2
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
|
Step 2
Unexpected Closure of Site
|
0
|
1
|
1
|
0
|
0
|
|
Step 2
Death
|
1
|
0
|
0
|
0
|
0
|
|
Step 2
Incarceration
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Baseline CD4 measurements were not obtained for three participants.
Baseline characteristics by cohort
| Measure |
Arm 1: Fiebig I/II
n=49 Participants
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 2: Fiebig III/IV
n=79 Participants
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 3: Fiebig V
n=60 Participants
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Fiebig VI
n=4 Participants
Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
HIV-negative
n=3 Participants
Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Region of Enrollment
Zimbabwe
|
0 Participants
n=49 Participants
|
0 Participants
n=79 Participants
|
6 Participants
n=60 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
8 Participants
n=195 Participants
|
|
Age, Continuous
|
26 years
n=49 Participants
|
30 years
n=79 Participants
|
26 years
n=60 Participants
|
36 years
n=4 Participants
|
25 years
n=3 Participants
|
27 years
n=195 Participants
|
|
Age, Customized
18-29 years
|
31 Participants
n=49 Participants
|
39 Participants
n=79 Participants
|
36 Participants
n=60 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
110 Participants
n=195 Participants
|
|
Age, Customized
30-39 years
|
12 Participants
n=49 Participants
|
18 Participants
n=79 Participants
|
12 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
43 Participants
n=195 Participants
|
|
Age, Customized
40-49 years
|
4 Participants
n=49 Participants
|
12 Participants
n=79 Participants
|
6 Participants
n=60 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
24 Participants
n=195 Participants
|
|
Age, Customized
50+ years
|
2 Participants
n=49 Participants
|
10 Participants
n=79 Participants
|
6 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
18 Participants
n=195 Participants
|
|
Sex/Gender, Customized
Cisgender
|
47 Participants
n=49 Participants
|
73 Participants
n=79 Participants
|
60 Participants
n=60 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
186 Participants
n=195 Participants
|
|
Sex/Gender, Customized
Transgender Spectrum
|
1 Participants
n=49 Participants
|
5 Participants
n=79 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=195 Participants
|
|
Sex/Gender, Customized
Not Reported
|
1 Participants
n=49 Participants
|
1 Participants
n=79 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=195 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=49 Participants
|
12 Participants
n=79 Participants
|
11 Participants
n=60 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
30 Participants
n=195 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=49 Participants
|
67 Participants
n=79 Participants
|
49 Participants
n=60 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
165 Participants
n=195 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=49 Participants
|
30 Participants
n=79 Participants
|
18 Participants
n=60 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
68 Participants
n=195 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=49 Participants
|
48 Participants
n=79 Participants
|
42 Participants
n=60 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
126 Participants
n=195 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants
|
1 Participants
n=79 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=195 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=49 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=195 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=49 Participants
|
1 Participants
n=79 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
14 Participants
n=195 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=195 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=49 Participants
|
35 Participants
n=79 Participants
|
39 Participants
n=60 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
97 Participants
n=195 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=49 Participants
|
36 Participants
n=79 Participants
|
16 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
66 Participants
n=195 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=49 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=195 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=49 Participants
|
7 Participants
n=79 Participants
|
4 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
17 Participants
n=195 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=49 Participants
|
65 Participants
n=79 Participants
|
42 Participants
n=60 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
133 Participants
n=195 Participants
|
|
Region of Enrollment
Malawi
|
4 Participants
n=49 Participants
|
3 Participants
n=79 Participants
|
3 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
11 Participants
n=195 Participants
|
|
Region of Enrollment
Brazil
|
6 Participants
n=49 Participants
|
10 Participants
n=79 Participants
|
8 Participants
n=60 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
25 Participants
n=195 Participants
|
|
Region of Enrollment
Thailand
|
12 Participants
n=49 Participants
|
1 Participants
n=79 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
13 Participants
n=195 Participants
|
|
Region of Enrollment
Peru
|
2 Participants
n=49 Participants
|
0 Participants
n=79 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=195 Participants
|
|
BMI
|
22.5 kg/m^2
n=49 Participants
|
25.9 kg/m^2
n=79 Participants
|
23.8 kg/m^2
n=60 Participants
|
22.7 kg/m^2
n=4 Participants
|
23.2 kg/m^2
n=3 Participants
|
24.0 kg/m^2
n=195 Participants
|
|
HIV-1 RNA (log10 copies per mL)
|
6.4 log10(copies per mL)
n=49 Participants
|
6.5 log10(copies per mL)
n=79 Participants
|
5.4 log10(copies per mL)
n=60 Participants
|
5.0 log10(copies per mL)
n=4 Participants
|
1.6 log10(copies per mL)
n=3 Participants
|
6.2 log10(copies per mL)
n=195 Participants
|
|
HIV-1 RNA
<40 copies per mL
|
0 Participants
n=49 Participants
|
0 Participants
n=79 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=195 Participants
|
|
HIV-1 RNA
40 - <1000 copies per mL
|
1 Participants
n=49 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=195 Participants
|
|
HIV-1 RNA
1000 - <10,000 copies per mL
|
0 Participants
n=49 Participants
|
2 Participants
n=79 Participants
|
6 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
8 Participants
n=195 Participants
|
|
HIV-1 RNA
10,000 - <100,000 copies per mL
|
9 Participants
n=49 Participants
|
4 Participants
n=79 Participants
|
10 Participants
n=60 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
24 Participants
n=195 Participants
|
|
HIV-1 RNA
100,000 - <1,000,000 copies per mL
|
9 Participants
n=49 Participants
|
13 Participants
n=79 Participants
|
23 Participants
n=60 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
46 Participants
n=195 Participants
|
|
HIV-1 RNA
1,000,000 - <10,000,000 copies per mL
|
17 Participants
n=49 Participants
|
39 Participants
n=79 Participants
|
16 Participants
n=60 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
72 Participants
n=195 Participants
|
|
HIV-1 RNA
>= 10,000,000 copies per mL
|
13 Participants
n=49 Participants
|
21 Participants
n=79 Participants
|
4 Participants
n=60 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
39 Participants
n=195 Participants
|
|
CD4 Count
|
348 cells per mm^3
n=48 Participants • Baseline CD4 measurements were not obtained for three participants.
|
383 cells per mm^3
n=78 Participants • Baseline CD4 measurements were not obtained for three participants.
|
490 cells per mm^3
n=60 Participants • Baseline CD4 measurements were not obtained for three participants.
|
436 cells per mm^3
n=4 Participants • Baseline CD4 measurements were not obtained for three participants.
|
1090 cells per mm^3
n=2 Participants • Baseline CD4 measurements were not obtained for three participants.
|
406 cells per mm^3
n=192 Participants • Baseline CD4 measurements were not obtained for three participants.
|
|
CD8 Count
|
322 cells per mm^3
n=47 Participants • Baseline CD8 measurements were not obtained for seven participants.
|
544 cells per mm^3
n=76 Participants • Baseline CD8 measurements were not obtained for seven participants.
|
1016 cells per mm^3
n=59 Participants • Baseline CD8 measurements were not obtained for seven participants.
|
1401 cells per mm^3
n=4 Participants • Baseline CD8 measurements were not obtained for seven participants.
|
474 cells per mm^3
n=2 Participants • Baseline CD8 measurements were not obtained for seven participants.
|
613 cells per mm^3
n=188 Participants • Baseline CD8 measurements were not obtained for seven participants.
|
|
Cell-associated HIV-1 DNA
Integrase Assay
|
7739 copies per 5 million CD4+ T-cells
n=49 Participants
|
15440 copies per 5 million CD4+ T-cells
n=79 Participants
|
10104 copies per 5 million CD4+ T-cells
n=60 Participants
|
4575 copies per 5 million CD4+ T-cells
n=4 Participants
|
0 copies per 5 million CD4+ T-cells
n=3 Participants
|
10507 copies per 5 million CD4+ T-cells
n=195 Participants
|
|
Cell-associated HIV-1 DNA
Gag Assay
|
4455 copies per 5 million CD4+ T-cells
n=49 Participants
|
6357 copies per 5 million CD4+ T-cells
n=79 Participants
|
5388 copies per 5 million CD4+ T-cells
n=60 Participants
|
3990 copies per 5 million CD4+ T-cells
n=4 Participants
|
0 copies per 5 million CD4+ T-cells
n=3 Participants
|
5586 copies per 5 million CD4+ T-cells
n=195 Participants
|
PRIMARY outcome
Timeframe: At week 48Population: Participants who maintained HIV-1 RNA\<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA \>200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA \<50 copies/mL ), had available CAHD results from week 48 or week 49, and were enrolled during Fiebig Stage I-V.
Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction \[qPCR\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
Outcome measures
| Measure |
Arm 1: Fiebig I/II
n=40 Participants
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 2: Fiebig III/IV
n=64 Participants
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 3: Fiebig V
n=50 Participants
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
|---|---|---|---|
|
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
Joint Assay (Integrase + Gag)
|
0.00 Proportion of participants
Interval 0.0 to 0.09
|
0.00 Proportion of participants
Interval 0.0 to 0.06
|
0.00 Proportion of participants
Interval 0.0 to 0.07
|
|
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
Integrase Assay
|
0.10 Proportion of participants
Interval 0.03 to 0.24
|
0.06 Proportion of participants
Interval 0.02 to 0.15
|
0.10 Proportion of participants
Interval 0.03 to 0.22
|
|
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
Gag Assay
|
0.03 Proportion of participants
Interval 0.0 to 0.13
|
0.02 Proportion of participants
Interval 0.0 to 0.08
|
0.00 Proportion of participants
Interval 0.0 to 0.07
|
SECONDARY outcome
Timeframe: At week 48Population: Participants who maintained HIV-1 RNA\<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA \>200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA \<50 copies/mL ), had available CAHD results from week 48 or week 49, had available immunology marker results where active control result is greater than or equal to the media control, and were enrolled during Fiebig Stage I-V.
Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
Outcome measures
| Measure |
Arm 1: Fiebig I/II
n=37 Participants
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 2: Fiebig III/IV
n=60 Participants
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 3: Fiebig V
n=46 Participants
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
|---|---|---|---|
|
HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
CD4+ T-cell Response to Env
|
0.00 Percentage of CD4+ T-cells
Interval 0.0 to 0.24
|
0.00 Percentage of CD4+ T-cells
Interval 0.0 to 0.09
|
0.08 Percentage of CD4+ T-cells
Interval 0.0 to 0.17
|
|
HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
CD4+ T-cell Response to Gag
|
0.06 Percentage of CD4+ T-cells
Interval 0.0 to 0.23
|
0.19 Percentage of CD4+ T-cells
Interval 0.03 to 0.31
|
0.14 Percentage of CD4+ T-cells
Interval 0.05 to 0.27
|
|
HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
CD4+ T-cell Response to Nef
|
0.04 Percentage of CD4+ T-cells
Interval 0.0 to 0.15
|
0.10 Percentage of CD4+ T-cells
Interval 0.0 to 0.26
|
0.10 Percentage of CD4+ T-cells
Interval 0.0 to 0.23
|
|
HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
CD4+ T-cell Response to Pol
|
0.00 Percentage of CD4+ T-cells
Interval 0.0 to 0.03
|
0.04 Percentage of CD4+ T-cells
Interval 0.0 to 0.13
|
0.04 Percentage of CD4+ T-cells
Interval 0.0 to 0.19
|
SECONDARY outcome
Timeframe: At 48 weeksPopulation: Participants who maintained HIV-1 RNA\<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA \>200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA \<50 copies/mL ), had available CAHD results from week 48 or week 49, had available immunology marker results where active control result is greater than or equal to the media control, and were enrolled during Fiebig Stage I-V.
Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
Outcome measures
| Measure |
Arm 1: Fiebig I/II
n=37 Participants
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 2: Fiebig III/IV
n=60 Participants
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 3: Fiebig V
n=46 Participants
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
|---|---|---|---|
|
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
CD8+ T-cell Response to Env
|
0.00 Percentage of CD8+ T-cells
Interval 0.0 to 0.03
|
0.00 Percentage of CD8+ T-cells
Interval 0.0 to 0.08
|
0.00 Percentage of CD8+ T-cells
Interval 0.0 to 0.36
|
|
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
CD8+ T-cell Response to Gag
|
0.15 Percentage of CD8+ T-cells
Interval 0.0 to 0.36
|
0.33 Percentage of CD8+ T-cells
Interval 0.06 to 0.67
|
0.28 Percentage of CD8+ T-cells
Interval 0.0 to 0.61
|
|
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
CD8+ T-cell Response to Nef
|
0.03 Percentage of CD8+ T-cells
Interval 0.0 to 0.32
|
0.15 Percentage of CD8+ T-cells
Interval 0.0 to 0.44
|
0.33 Percentage of CD8+ T-cells
Interval 0.04 to 0.68
|
|
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
CD8+ T-cell Response to Pol
|
0.00 Percentage of CD8+ T-cells
Interval 0.0 to 0.08
|
0.05 Percentage of CD8+ T-cells
Interval 0.0 to 0.23
|
0.08 Percentage of CD8+ T-cells
Interval 0.0 to 0.26
|
SECONDARY outcome
Timeframe: At week 0Population: All participants who enrolled during Fiebig Stage I-V and had available CAHD at week 0.
Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR \[qPCR\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
Outcome measures
| Measure |
Arm 1: Fiebig I/II
n=48 Participants
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 2: Fiebig III/IV
n=78 Participants
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Arm 3: Fiebig V
n=60 Participants
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
|---|---|---|---|
|
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
Joint Assay (Integrase + Gag)
|
0.00 Proportion of participants
Interval 0.0 to 0.07
|
0.01 Proportion of participants
Interval 0.0 to 0.07
|
0.00 Proportion of participants
Interval 0.0 to 0.06
|
|
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
Integrase Assay
|
0.04 Proportion of participants
Interval 0.01 to 0.14
|
0.03 Proportion of participants
Interval 0.0 to 0.09
|
0.07 Proportion of participants
Interval 0.02 to 0.16
|
|
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
Gag Assay
|
0.00 Proportion of participants
Interval 0.0 to 0.07
|
0.01 Proportion of participants
Interval 0.0 to 0.07
|
0.00 Proportion of participants
Interval 0.0 to 0.06
|
Adverse Events
Step 1 Arm 1: Fiebig I/II
Serious events: 5 serious events
Other events: 48 other events
Deaths: 0 deaths
Step 1 Arm 2: Fiebig III/IV
Serious events: 7 serious events
Other events: 67 other events
Deaths: 0 deaths
Step 1 Arm 3: Fiebig V
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Step 1 Fiebig VI
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Step1 HIV Negative
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Step 2 Arm 1: Fiebig I/II
Serious events: 6 serious events
Other events: 18 other events
Deaths: 1 deaths
Step 2 Arm 2: Fiebig III/IV
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Step 2 Arm 3: Fiebig V
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Step 1 Arm 1: Fiebig I/II
n=49 participants at risk
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 1 Arm 2: Fiebig III/IV
n=79 participants at risk
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 1 Arm 3: Fiebig V
n=60 participants at risk
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 1 Fiebig VI
n=4 participants at risk
Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step1 HIV Negative
n=3 participants at risk
Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
|
Step 2 Arm 1: Fiebig I/II
n=26 participants at risk
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody) that enrolled to Step 2.
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 2 Arm 2: Fiebig III/IV
n=42 participants at risk
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2) that enrolled to Step 2.
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 2 Arm 3: Fiebig V
n=23 participants at risk
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band) that enrolled to Step 2.
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
COVID-19
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Fascial infection
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Monkeypox
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Secondary syphilis
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Hepatitis B surface antigen positive
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Panic attack
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Suicidal ideation
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Suicide attempt
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Skin and subcutaneous tissue disorders
Vascular skin disorder
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
Other adverse events
| Measure |
Step 1 Arm 1: Fiebig I/II
n=49 participants at risk
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 1 Arm 2: Fiebig III/IV
n=79 participants at risk
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 1 Arm 3: Fiebig V
n=60 participants at risk
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 1 Fiebig VI
n=4 participants at risk
Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step1 HIV Negative
n=3 participants at risk
Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
|
Step 2 Arm 1: Fiebig I/II
n=26 participants at risk
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody) that enrolled to Step 2.
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 2 Arm 2: Fiebig III/IV
n=42 participants at risk
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2) that enrolled to Step 2.
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
Step 2 Arm 3: Fiebig V
n=23 participants at risk
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band) that enrolled to Step 2.
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Cardiac disorders
Palpitations
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Congenital, familial and genetic disorders
Thalassaemia
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Eye disorders
Chalazion
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
General disorders
Fatigue
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.5%
2/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
General disorders
Pain
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
General disorders
Pyrexia
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Acute hepatitis C
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Anal chlamydia infection
|
8.2%
4/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.3%
2/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
19.2%
5/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.8%
2/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Anal gonococcal infection
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
7.7%
2/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Bacterial diarrhoea
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Body tinea
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
COVID-19
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.8%
2/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.3%
2/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Chlamydial cervicitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.5%
2/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.8%
2/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Genitourinary chlamydia infection
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Helicobacter gastritis
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Herpes simplex anorectal
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Hordeolum
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Large intestine infection
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Latent syphilis
|
8.2%
4/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.5%
2/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
15.4%
4/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
9.5%
4/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Monkeypox
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Neurosyphilis
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Oesophageal candidiasis
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
8.2%
4/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
5.0%
3/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Pharyngeal chlamydia infection
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
7.7%
2/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Primary syphilis
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
7.7%
2/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.8%
2/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Proctitis chlamydial
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
9.5%
4/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
17.4%
4/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Proctitis gonococcal
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
3/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
5.0%
3/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Scabies
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Secondary syphilis
|
8.2%
4/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
6.3%
5/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
5.0%
3/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
7.7%
2/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.8%
2/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Shigella infection
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Syphilis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Syphilis genital
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
3/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Urethritis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Urethritis chlamydial
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.3%
2/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Urethritis gonococcal
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Urethritis ureaplasmal
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Urinary tract infection
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.5%
2/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Infections and infestations
Vulvovaginitis gonococcal
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Alanine aminotransferase increased
|
12.2%
6/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
6.3%
5/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.3%
2/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Aspartate aminotransferase increased
|
10.2%
5/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
6.3%
5/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
6.7%
4/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Bilirubin conjugated increased
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood bilirubin increased
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
11.5%
3/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood creatine increased
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood creatinine increased
|
32.7%
16/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
29.1%
23/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
26.7%
16/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
7.7%
2/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
9.5%
4/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
17.4%
4/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood glucose increased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
3/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.8%
2/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood pressure increased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.8%
2/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Chlamydia test positive
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Creatinine renal clearance decreased
|
75.5%
37/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
77.2%
61/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
75.0%
45/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
100.0%
4/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
66.7%
2/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
21.4%
9/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
8.7%
2/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Glomerular filtration rate decreased
|
10.2%
5/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Hepatic enzyme increased
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Liver function test abnormal
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
11.5%
3/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Neisseria test positive
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.3%
2/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Platelet count decreased
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Syphilis test positive
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Trichomonal test positive
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Tuberculin test positive
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Investigations
Weight decreased
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.3%
2/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal papilloma
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.5%
2/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Nervous system disorders
Headache
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Nervous system disorders
Tremor
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Adjustment disorder with mixed anxiety and depressed mood
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Agitated depression
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Anxiety
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Depressed mood
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Depression
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.3%
2/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Psychiatric disorders
Suicidal ideation
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Renal and urinary disorders
Dysuria
|
2.0%
1/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
4.3%
1/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.3%
1/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
|
Vascular disorders
Hypertension
|
4.1%
2/49 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.5%
2/79 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
1.7%
1/60 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
25.0%
1/4 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/3 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
3.8%
1/26 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
2.4%
1/42 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
0.00%
0/23 • Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER