Trial Outcomes & Findings for Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents (NCT NCT03332095)
NCT ID: NCT03332095
Last Updated: 2023-02-14
Results Overview
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to infinity. Steady state AUC0-24 is equivalent to single dose AUC0-∞.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.
Results posted on
2023-02-14
Participant Flow
Participants were enrolled from July 2018 to February 2020. Participants were recruited from 8 medical clinics in the United States, Thailand and South Africa.
There was no randomization. Enrollment started with Cohort 1, then Cohort 2 was open.
Participant milestones
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not provided by the study.
|
Cohort 2: DOR/3TC/TDF
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
45
|
|
Overall Study
Received at Least One Dose of Study Treatment
|
9
|
45
|
|
Overall Study
COMPLETED
|
9
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not provided by the study.
|
Cohort 2: DOR/3TC/TDF
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents
Baseline characteristics by cohort
| Measure |
Cohort 1: DOR
n=9 Participants
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
15.0 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
14.9 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
55.9 kg
STANDARD_DEVIATION 15.8 • n=5 Participants
|
53.8 kg
STANDARD_DEVIATION 8.0 • n=7 Participants
|
54.1 kg
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Weight Band (kg)
35 - <45 kg
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Weight Band (kg)
≥ 45 kg
|
8 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region
Africa
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region
Asia/Pacific
|
0 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region
North America
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Class of Prior ARTs
Nucleoside Reverse Transcriptase Inhibitors (NRTI)
|
9 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Class of Prior ARTs
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
|
0 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Class of Prior ARTs
Integrase Strand Transfer Inhibitors (INSTI)
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Class of Prior ARTs
Protease Inhibitors (PI)
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Class of Prior ARTs
Not Applicable
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
0 - <40
|
9 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
40 - <500,000
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
500,000 - <1,000,000
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Duration of Prior ARTs
|
614.2 days
STANDARD_DEVIATION 511.3 • n=5 Participants
|
1882.3 days
STANDARD_DEVIATION 1649.6 • n=7 Participants
|
1662.8 days
STANDARD_DEVIATION 1589.4 • n=5 Participants
|
|
CD4 Cell Count
|
788.2 cells/mm^3
STANDARD_DEVIATION 203.9 • n=5 Participants
|
717.8 cells/mm^3
STANDARD_DEVIATION 283.1 • n=7 Participants
|
729.7 cells/mm^3
STANDARD_DEVIATION 270.9 • n=5 Participants
|
|
CD4%
|
36.2 percent
STANDARD_DEVIATION 5.4 • n=5 Participants
|
33.1 percent
STANDARD_DEVIATION 9.1 • n=7 Participants
|
33.6 percent
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
HIV-1 log10 RNA
|
1.6 log10 copies/mL
STANDARD_DEVIATION 0.0 • n=5 Participants
|
1.8 log10 copies/mL
STANDARD_DEVIATION 0.9 • n=7 Participants
|
1.7 log10 copies/mL
STANDARD_DEVIATION 0.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.Population: Cohort 1 participants who received the study treatment.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to infinity. Steady state AUC0-24 is equivalent to single dose AUC0-∞.
Outcome measures
| Measure |
Cohort 1: DOR
n=9 Participants
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter: Single-dose Area-under-the-curve (AUC0-∞) of Doravirine (DOR) (Cohort 1)
|
34.8 µM*hr
Geometric Coefficient of Variation 43.2
|
—
|
PRIMARY outcome
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.Population: Cohort 1 participants who received the study treatment.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA).
Outcome measures
| Measure |
Cohort 1: DOR
n=9 Participants
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: Single-dose Maximum Concentration (Cmax) of DOR (Cohort 1)
|
2.14 µM
Geometric Coefficient of Variation 25.9
|
—
|
PRIMARY outcome
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.Population: Cohort 1 participants who received the study treatment.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA).
Outcome measures
| Measure |
Cohort 1: DOR
n=9 Participants
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: Single-dose 24 Hour-concentration (C24hr) of DOR (Cohort 1)
|
514 nM
Geometric Coefficient of Variation 56.5
|
—
|
PRIMARY outcome
Timeframe: Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.Population: Study participants who received at least one dose of study treatment were included.
Percentage and Clopper-Pearson 95% Confidence Interval (CI) of participants with Grade 3 or higher AEs judged by the medical clinic as related to the study drug. AEs were graded based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017 (see References).
Outcome measures
| Measure |
Cohort 1: DOR
n=9 Participants
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
|
0 percentage of participants
Interval 0.0 to 33.6
|
0 percentage of participants
Interval 0.0 to 7.9
|
PRIMARY outcome
Timeframe: Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.Population: Study participants who received at least one dose of study treatment were included.
Percentage and Clopper-Pearson 95% CI of participants with SAEs judged by the medical clinic as related to the study drug. SAEs were reported according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) (see references).
Outcome measures
| Measure |
Cohort 1: DOR
n=9 Participants
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Assessed as Related to Study Drug
|
0 percentage of participants
Interval 0.0 to 33.6
|
0 percentage of participants
Interval 0.0 to 7.9
|
PRIMARY outcome
Timeframe: Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.Population: Study Participants who received at least one dose of study treatment were included.
Percentage and Clopper-Pearson 95% CI of participants with permanent discontinuation of study drug due to AEs judged by the medical clinic as related to the study drug.
Outcome measures
| Measure |
Cohort 1: DOR
n=9 Participants
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug
|
0 percentage of participants
Interval 0.0 to 33.6
|
0 percentage of participants
Interval 0.0 to 7.9
|
PRIMARY outcome
Timeframe: Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.Population: Study participants who received at least one dose of study treatment were included.
Percentage and Clopper-Pearson 95% CI of participants with Grade 5 AEs (death) regardless of relationship to study drug.
Outcome measures
| Measure |
Cohort 1: DOR
n=9 Participants
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug
|
0 percentage of participants
Interval 0.0 to 33.6
|
0 percentage of participants
Interval 0.0 to 7.9
|
SECONDARY outcome
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.Population: The first 10 participants enrolled in Cohort 2.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=10 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: AUC0-24hr of DOR (Cohort 2)
|
—
|
22.9 µM*hr
Geometric Coefficient of Variation 47.0
|
SECONDARY outcome
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.Population: The first 10 participants enrolled in Cohort 2.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=10 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: AUC0-24hr of 3TC (Cohort 2)
|
—
|
11300 h.ng/mL
Geometric Coefficient of Variation 27.9
|
SECONDARY outcome
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.Population: The first 10 participants enrolled in Cohort 2.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=10 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: AUC0-24hr of Tenofovir (Cohort 2)
|
—
|
2550 h.ng/mL
Geometric Coefficient of Variation 14.3
|
SECONDARY outcome
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.Population: The first 10 participants enrolled in Cohort 2.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=10 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: Cmax of DOR (Cohort 2)
|
—
|
2.13 µM
Geometric Coefficient of Variation 42.7
|
SECONDARY outcome
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.Population: The first 10 participants enrolled in Cohort 2.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=10 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: Cmax of 3TC (Cohort 2)
|
—
|
2100 ng/mL
Geometric Coefficient of Variation 23.6
|
SECONDARY outcome
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.Population: The first 10 participants enrolled in Cohort 2.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=10 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: Cmax of Tenofovir (Cohort 2)
|
—
|
293 ng/mL
Geometric Coefficient of Variation 36.6
|
SECONDARY outcome
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.Population: The first 10 participants enrolled in Cohort 2.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=10 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: C24hr of DOR (Cohort 2)
|
—
|
282 nM
Geometric Coefficient of Variation 73.8
|
SECONDARY outcome
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.Population: The first 10 participants enrolled in Cohort 2.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=10 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: C24hr of 3TC (Cohort 2)
|
—
|
66.3 ng/mL
Geometric Coefficient of Variation 54.7
|
SECONDARY outcome
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.Population: The first 10 participants enrolled in Cohort 2.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=10 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
PK Parameter: C24hr of Tenofovir (Cohort 2)
|
—
|
50.2 ng/mL
Geometric Coefficient of Variation 9.4
|
SECONDARY outcome
Timeframe: Measured at week 24.Population: Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded.
Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA \>200 copies/mL; otherwise participants with missing values were excluded.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=44 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 24 (Cohort 2)
|
—
|
97.7 Percentage of participants
Interval 88.0 to 99.9
|
SECONDARY outcome
Timeframe: Measured at week 48.Population: Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded.
Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA \>200 copies/mL; otherwise participants with missing values were excluded.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=44 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 48 (Cohort 2)
|
—
|
97.7 Percentage of participants
Interval 88.0 to 99.9
|
SECONDARY outcome
Timeframe: Measured at week 96.Population: Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded.
Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA \>200 copies/mL; otherwise participants with missing values were excluded.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=42 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 96 (Cohort 2)
|
—
|
92.9 Percentage of participants
Interval 80.5 to 98.5
|
SECONDARY outcome
Timeframe: Measured at week 24.Population: Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded. One participant whose sample was diluted due to low volume, resulting in increased assay limit of quantification from 40 to 200 copies/mL was excluded.
Virologic responses were assessed at week 24 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA \>50 copies/mL. Otherwise participants with missing values were excluded.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=43 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 24 (Cohort 2)
|
—
|
97.7 Percentage of participants
Interval 87.7 to 99.9
|
SECONDARY outcome
Timeframe: Measured at week 48.Population: Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded. Two participants whose sample was diluted due to low volume, resulting in increased assay limit of quantification from 40 to 200 copies/mL were excluded.
Virologic responses were assessed at week 48 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA \>50 copies/mL. Otherwise participants with missing values were excluded.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=42 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 48 (Cohort 2)
|
—
|
97.6 Percentage of participants
Interval 87.4 to 99.9
|
SECONDARY outcome
Timeframe: Measured at week 96.Population: Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded. Two participant whose sample was diluted due to low volume, resulting in increased assay limit of quantification from 40 to 200 copies/mL were excluded.
Virologic responses were assessed at week 96 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA \>50 copies/mL. Otherwise participants with missing values were excluded.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=40 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 96 (Cohort 2)
|
—
|
92.5 Percentage of participants
Interval 79.6 to 98.4
|
SECONDARY outcome
Timeframe: Measured at week 24.Population: Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded. One participant whose sample was diluted due to low volume, resulting in increased assay limit of quantification from 40 to 200 copies/mL was excluded.
Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA \>40 copies/mL; Otherwise participants with missing values were excluded.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=43 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 24 (Cohort 2)
|
—
|
97.7 Percentage of participants
Interval 87.7 to 99.9
|
SECONDARY outcome
Timeframe: Measured at week 48.Population: Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded. One participant whose sample was diluted due to low volume, resulting in increased assay limit of quantification from 40 to 200 copies/mL was excluded.
Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA \>40 copies/mL; Otherwise participants with missing values were excluded.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=42 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 48 (Cohort 2)
|
—
|
97.6 Percentage of participants
Interval 87.4 to 99.9
|
SECONDARY outcome
Timeframe: Measured at week 96.Population: Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded. Two participants whose sample was diluted due to low volume, resulting in increased assay limit of quantification from 40 to 200 copies/mL were excluded.
Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA \>40 copies/mL; Otherwise participants with missing values were excluded.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=40 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 96 (Cohort 2)
|
—
|
92.5 Percentage of participants
Interval 79.6 to 98.4
|
SECONDARY outcome
Timeframe: Measured at Day 0 and week 24.Population: Cohort 2 participants who were ART-naive.
The differences between log10 HIV RNA at Week 24 minus at Day 0 are summarized.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=2 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Summary of log10 Drop From Baseline to Week 24 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
|
—
|
-2.6 Log10 plasma HIV-1 RNA
Interval -5.8 to 19.0
|
SECONDARY outcome
Timeframe: Measured at Day 0 and week 48.Population: Cohort 2 participants who were ART-naive.
The differences between log10 HIV RNA at Week 48 minus at Day 0 are summarized.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=2 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Summary of log10 Drop From Baseline to Week 48 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
|
—
|
-2.1 Log10 plasma HIV-1 RNA
Interval -5.8 to 26.1
|
SECONDARY outcome
Timeframe: Measured at Day 0 and week 96.Population: Cohort 2 participants who were ART-naive.
The differences between log10 HIV RNA at Week 96 minus at Day 0 are summarized.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=1 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Summary of log10 Drop From Baseline to Week 96 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
|
—
|
-4.3 Log10 plasma HIV-1 RNA
|
SECONDARY outcome
Timeframe: Measured at Day 0 and week 24.Population: Cohort 2 participants who had non-missing values at both Day 0 and Week 24 timepoints.
The mean difference is calculated as CD4 count at Week 24 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=43 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Summary of Changes in CD4 Count From Baseline to Week 24 (Cohort 2)
|
—
|
84.8 cells/mm^3
Interval 21.1 to 148.4
|
SECONDARY outcome
Timeframe: Measured at Day 0 and week 48.Population: Cohort 2 participants who had non-missing values at both Day 0 and Week 48 timepoints.
The mean differences is calculated as CD4 count at Week 48 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=43 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Summary of Changes in CD4 Count From Baseline to Week 48 (Cohort 2)
|
—
|
80.1 cells/mm^3
Interval 14.2 to 146.0
|
SECONDARY outcome
Timeframe: Measured at Day 0 and week 96.Population: Cohort 2 participants who had non-missing values at both Day 0 and Week 96 timepoints.
The mean difference is calculated as CD4 count at Week 96 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=38 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Summary of Changes in CD4 Count From Baseline to Week 96 (Cohort 2)
|
—
|
42.5 cells/mm^3
Interval -31.1 to 116.1
|
SECONDARY outcome
Timeframe: Measured at Day 0 and week 24.Population: Cohort 2 participants who had non-missing values at both Day 0 and Week 24 timepoints.
The mean difference is calculated as CD4% at Week 24 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=43 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Summary of Changes in CD4% From Baseline to Week 24 (Cohort 2)
|
—
|
-1.5 Percent of total lymphocytes
Interval -2.8 to -0.2
|
SECONDARY outcome
Timeframe: Measured at Day 0 and week 48.Population: Cohort 2 participants who had non-missing values at both Day 0 and Week 48 timepoints.
The mean difference is calculated as CD4% at Week 48 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=43 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Summary of Changes in CD4% From Baseline to Week 48 (Cohort 2)
|
—
|
-0.4 Percent of total lymphocytes
Interval -1.7 to 0.9
|
SECONDARY outcome
Timeframe: Measured at Day 0 and week 96.Population: Cohort 2 participants who had non-missing values at both Day 0 and Week 96 timepoints.
The mean difference is calculated as CD4% at Week 96 minus CD4% at the Day 0 with associated 95% Clopper-Pearson CI.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=38 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Summary of Changes in CD4% From Baseline to Week 96 (Cohort 2)
|
—
|
-0.5 Percent of total lymphocytes
Interval -2.5 to 1.5
|
SECONDARY outcome
Timeframe: Measured from Day 0 through Week 96.Population: Study participants who received at least one dose of study treatment were included.
Percentage and Clopper-Pearson 95% CI of participants with Grade 3 or higher AEs judged by the medical clinic as related to the study drug. AEs were graded based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017 (DAIDS) AE Grading table corrected version 2.1 (see References).
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Grade 3 or Higher Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study
|
—
|
0 Percentage of participants
Interval 0.0 to 7.9
|
SECONDARY outcome
Timeframe: Measured from Day 0 through Week 96.Population: Study participants who received at least one dose of study treatment were included.
Percentage and Clopper-Pearson 95% CI of participants with SAEs judged by the medical clinic as related to the study drug. SAEs were reported according to version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) (see references).
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study
|
—
|
0 Percentage of participants
Interval 0.0 to 7.9
|
SECONDARY outcome
Timeframe: Measured from Day 0 through Week 96.Population: Study Participants who received at least one dose of study treatment were included.
Percentage and Clopper-Pearson 95% CI of participants with permanent discontinuation of study drug due to AEs judged by the medical clinic as related to the study drug.
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study
|
—
|
0 Percentage of participants
Interval 0.0 to 7.9
|
SECONDARY outcome
Timeframe: Measured from Day 0 through Week 96.Population: Study participants who received at least one dose of study treatment were included.
Percentage and Clopper-Pearson 95% CI of participants with Grade 5 adverse events (death).
Outcome measures
| Measure |
Cohort 1: DOR
Participants received a single dose of DOR at study entry (Day 0).
Doravirine (DOR): 100 mg of DOR administered orally
Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 Participants
Participants received DOR/3TC/TDF from Day 0 through Week 96.
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug (Cohort 2) Through End of Study
|
—
|
0 percentage of participants
Interval 0.0 to 7.9
|
Adverse Events
Cohort 1: DOR
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: DOR/3TC/TDF
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: DOR
n=9 participants at risk
Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 participants at risk
Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
Other adverse events
| Measure |
Cohort 1: DOR
n=9 participants at risk
Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
|
Cohort 2: DOR/3TC/TDF
n=45 participants at risk
Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily.
|
|---|---|---|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Eye disorders
Conjunctival pallor
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
6.7%
3/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
13.3%
6/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Salivary gland mucocoele
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
General disorders
Chest pain
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
General disorders
Face oedema
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
General disorders
Fatigue
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
General disorders
Injection site pain
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
General disorders
Malaise
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
6.7%
3/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
6.7%
3/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
8.9%
4/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Urethritis
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Urethritis gonococcal
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Adverse event following immunisation
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
11.1%
5/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
46.7%
21/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
33.3%
15/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
6.7%
3/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
11.1%
1/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
31.1%
14/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
26.7%
12/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
15.6%
7/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
46.7%
21/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
13.3%
6/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood glucose increased
|
11.1%
1/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
17.8%
8/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
8.9%
4/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood phosphorus increased
|
11.1%
1/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
0.00%
0/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
20.0%
9/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood potassium increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood pressure increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
17.8%
8/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
15.6%
7/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
6.7%
3/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
24.4%
11/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
55.6%
25/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
15.6%
7/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Lipase increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
17.8%
8/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
6.7%
3/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
6.7%
3/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
8.9%
4/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Bone callus excessive
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
20.0%
9/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Tension
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
6.7%
3/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
13.3%
6/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Urethral discharge
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Bleeding anovulatory
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
20.0%
9/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
13.3%
6/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
11.1%
5/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
11.1%
5/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
17.8%
8/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
8.9%
4/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
6.7%
3/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
8.9%
4/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
2.2%
1/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
4.4%
2/45 • From start of study treatment to study completion at Week 2 in Cohort 1 or at Week 96 in Cohort 2.
AEs were summarized for participants who received at least one dose, and included abnormal laboratory events with specimen collection dates greater than first dose date and AEs that are not abnormal laboratory events and have onset dates equal to or greater than study drug's first dose date. AES were restricted to those with start dates less than or equal to the PCD. AE severity grading was based on the DAIDS AE Grading Table, Corrected Version 2.1. SAE were graded using DAIDS EAE Manual V2.0.
|
Additional Information
Melissa Allen, Director, IMPAACT Operations Center
Family Health International (FHI 360)
Phone: (919) 405-1429
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