Trial Outcomes & Findings for FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir (NCT NCT01777997)
NCT ID: NCT01777997
Last Updated: 2021-08-03
Results Overview
Mean change from baseline (pre-ART \[study entry\] and week 0 on ART \[study week 12\]), estimated with a repeated measures analysis (jointly to weeks 24 and 48 on ART) using generalized estimating equations (GEE)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
From baseline (pre-ART and week 0 on ART) to weeks 24 and 48 on ART
Results posted on
2021-08-03
Participant Flow
Recruited at 19 Clinical Research Sites (CRSs) in the United States between April 25, 2013 and December 22, 2014.
Participant milestones
| Measure |
FTC/RPV/TDF
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily. Participants in the primary outcome analysis were on ART for at least 24 weeks and up to 48 weeks.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment. Participants in exploratory analyses were on ART for at least 72 weeks and up to 96 weeks.
|
|---|---|
|
12 Week lead-in of no ART
STARTED
|
38
|
|
12 Week lead-in of no ART
COMPLETED
|
36
|
|
12 Week lead-in of no ART
NOT COMPLETED
|
2
|
|
Weeks 0 to 24/48 on ART
STARTED
|
36
|
|
Weeks 0 to 24/48 on ART
COMPLETED
|
35
|
|
Weeks 0 to 24/48 on ART
NOT COMPLETED
|
1
|
|
Weeks 48 to 72/96 on ART
STARTED
|
28
|
|
Weeks 48 to 72/96 on ART
COMPLETED
|
26
|
|
Weeks 48 to 72/96 on ART
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
FTC/RPV/TDF
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily. Participants in the primary outcome analysis were on ART for at least 24 weeks and up to 48 weeks.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment. Participants in exploratory analyses were on ART for at least 72 weeks and up to 96 weeks.
|
|---|---|
|
12 Week lead-in of no ART
Severe debilitation
|
2
|
|
Weeks 0 to 24/48 on ART
Participant felt treatment not working
|
1
|
|
Weeks 48 to 72/96 on ART
Death
|
1
|
|
Weeks 48 to 72/96 on ART
Took prohibited/precautionary meds
|
1
|
Baseline Characteristics
FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir
Baseline characteristics by cohort
| Measure |
FTC/RPV/TDF
n=35 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black non-Hispanic
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic (regardless of race)
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
|
CD4+ T-cell count
|
682 cells/mm^3
n=5 Participants
|
|
HIV-1 RNA by Abbott Assay
Pre-ART (study entry) · <40 copies/mL
|
16 Participants
n=5 Participants
|
|
HIV-1 RNA by Abbott Assay
Pre-ART (study entry) · >=40 copies/mL
|
19 Participants
n=5 Participants
|
|
HIV-1 RNA by Abbott Assay
Week 0 on ART (study week 12) · <40 copies/mL
|
13 Participants
n=5 Participants
|
|
HIV-1 RNA by Abbott Assay
Week 0 on ART (study week 12) · >=40 copies/mL
|
22 Participants
n=5 Participants
|
|
Percentage of CD8+ T-cells that are CD38+HLA-DR+
|
24.6 % of CD8+ T-cells
n=5 Participants
|
|
Percentage of CD4+ T-cells that are CD38+HLA-DR+
|
2.6 % of CD4+ T-cells
n=5 Participants
|
|
Interleukin (IL)-6
|
0.17 log10(pg/mL)
n=5 Participants
|
|
D-dimer
|
2.58 log10(ng/mL)
n=5 Participants
|
|
Quality of life (QoL) index
|
0.2 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 24 and 48 on ARTPopulation: As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA \<200 copies/mL for at least 2 weeks (14 days) prior to week 24 or 48 weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.
Mean change from baseline (pre-ART \[study entry\] and week 0 on ART \[study week 12\]), estimated with a repeated measures analysis (jointly to weeks 24 and 48 on ART) using generalized estimating equations (GEE)
Outcome measures
| Measure |
FTC/RPV/TDF
n=35 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART
|
-4.01 % of CD8+ T-cells
Interval -6.41 to -1.61
|
SECONDARY outcome
Timeframe: At pre-ART and weeks 0, 4, 12, 24, 36 and 48 on ARTPopulation: As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA \<200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.
At a specific week, the proportion of participants with HIV-1 RNA by iSCA less than assay limit of detection (0.6 copies/mL)
Outcome measures
| Measure |
FTC/RPV/TDF
n=35 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
Pre-ART
|
0.19 proportion of participants
|
|
Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
Week 0 on ART
|
0.19 proportion of participants
|
|
Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
Week 4 on ART
|
0.61 proportion of participants
|
|
Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
Week 12 on ART
|
0.90 proportion of participants
|
|
Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
Week 24 on ART
|
0.93 proportion of participants
|
|
Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
Week 36 on ART
|
0.92 proportion of participants
|
|
Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
Week 48 on ART
|
0.96 proportion of participants
|
SECONDARY outcome
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 12, 24, 36 and 48 on ARTPopulation: As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA \<200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.
Change equals each specific week CD4+ T-cell count, respectively, minus the baseline CD4+ T-cell count (mean of the two measurements obtained prior to the start of ART)
Outcome measures
| Measure |
FTC/RPV/TDF
n=35 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Change in CD4+ T-cell Count
Week 12 on ART
|
-15 cells/mm^3
Interval -124.0 to 64.0
|
|
Change in CD4+ T-cell Count
Week 24 on ART
|
-5 cells/mm^3
Interval -112.0 to 68.0
|
|
Change in CD4+ T-cell Count
Week 36 on ART
|
25 cells/mm^3
Interval -43.0 to 154.0
|
|
Change in CD4+ T-cell Count
Week 48 on ART
|
19 cells/mm^3
Interval -108.0 to 103.0
|
SECONDARY outcome
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ARTPopulation: As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA \<200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.
Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART)
Outcome measures
| Measure |
FTC/RPV/TDF
n=35 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Change in Levels of CD8+ T-cell Activation
Week 4 on ART
|
-0.7 % of CD8+ T-cells
Interval -4.7 to 4.2
|
|
Change in Levels of CD8+ T-cell Activation
Week 12 on ART
|
-1.6 % of CD8+ T-cells
Interval -6.2 to 4.5
|
|
Change in Levels of CD8+ T-cell Activation
Week 24 on ART
|
-2.2 % of CD8+ T-cells
Interval -6.1 to 0.0
|
|
Change in Levels of CD8+ T-cell Activation
Week 48 on ART
|
-4.7 % of CD8+ T-cells
Interval -7.4 to 0.3
|
SECONDARY outcome
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ARTPopulation: As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA \<200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.
Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART)
Outcome measures
| Measure |
FTC/RPV/TDF
n=35 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)
Week 4 on ART
|
0.1 % of CD4+ T-cells
Interval -0.6 to 1.0
|
|
Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)
Week 12 on ART
|
-0.1 % of CD4+ T-cells
Interval -0.4 to 0.7
|
|
Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)
Week 24 on ART
|
-0.2 % of CD4+ T-cells
Interval -0.8 to 0.1
|
|
Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)
Week 48 on ART
|
-0.2 % of CD4+ T-cells
Interval -0.9 to 0.4
|
SECONDARY outcome
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ARTPopulation: As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA \<200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.
Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART)
Outcome measures
| Measure |
FTC/RPV/TDF
n=35 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Change in Levels of Interleukin (IL)-6
Week 4 on ART
|
0.05 log10(pg/mL)
Interval -0.07 to 0.16
|
|
Change in Levels of Interleukin (IL)-6
Week 12 on ART
|
0.01 log10(pg/mL)
Interval -0.14 to 0.15
|
|
Change in Levels of Interleukin (IL)-6
Week 24 on ART
|
0.02 log10(pg/mL)
Interval -0.06 to 0.18
|
|
Change in Levels of Interleukin (IL)-6
Week 48 on ART
|
0 log10(pg/mL)
Interval -0.14 to 0.14
|
SECONDARY outcome
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ARTPopulation: As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA \<200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.
Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART)
Outcome measures
| Measure |
FTC/RPV/TDF
n=35 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Change in Levels of D-dimer
Week 4 on ART
|
0.01 log10(ng/mL)
Interval -0.12 to 0.16
|
|
Change in Levels of D-dimer
Week 24 on ART
|
0.01 log10(ng/mL)
Interval -0.19 to 0.3
|
|
Change in Levels of D-dimer
Week 48 on ART
|
0.02 log10(ng/mL)
Interval -0.2 to 0.26
|
SECONDARY outcome
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ARTPopulation: As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA \<200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.
QoL index was obtained by averaging the five responses on the Euro-Quality of Life questionnaire (EQ-5D), where a response of 0 indicates "no problems/no discomfort", 1 indicates "some problems/moderate discomfort" and 2 indicates "unable to perform activities/extreme discomfort". Change equals each specific week index, respectively, minus the baseline index (mean of the two averages obtained prior to the start of ART)
Outcome measures
| Measure |
FTC/RPV/TDF
n=35 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Change in Quality of Life (QoL) Index
Week 4 on ART
|
0 units on a scale
Interval -0.1 to 0.0
|
|
Change in Quality of Life (QoL) Index
Week 24 on ART
|
-0.1 units on a scale
Interval -0.2 to 0.0
|
|
Change in Quality of Life (QoL) Index
Week 48 on ART
|
0 units on a scale
Interval -0.1 to 0.0
|
SECONDARY outcome
Timeframe: From initiation of treatment to study completion at week 60 or 108 or premature study discontinuationPopulation: All participants who initiated ART, regardless of ART status at time of event
Grading uses the Division of AIDS (DAIDS) 2004 (clarification 2009) Severity of Adverse Events Table, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.
Outcome measures
| Measure |
FTC/RPV/TDF
n=36 Participants
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs)
|
18 participants
|
Adverse Events
FTC/RPV/TDF
Serious events: 1 serious events
Other events: 23 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
FTC/RPV/TDF
n=36 participants at risk
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Infections and infestations
Bronchitis
|
2.8%
1/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
Other adverse events
| Measure |
FTC/RPV/TDF
n=36 participants at risk
Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
|
|---|---|
|
Eye disorders
Eye pruritus
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
4/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Gastrointestinal disorders
Proctalgia
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
4/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
General disorders
Fatigue
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
General disorders
Peripheral swelling
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
General disorders
Pyrexia
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Infections and infestations
Acarodermatitis
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Infections and infestations
Bacterial vaginosis
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Investigations
Alanine aminotransferase increased
|
13.9%
5/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
4/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Investigations
Blood bilirubin increased
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Investigations
Blood creatinine increased
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Investigations
Blood glucose increased
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Investigations
Blood phosphorus decreased
|
13.9%
5/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Investigations
Blood sodium decreased
|
13.9%
5/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Investigations
Neutrophil count decreased
|
11.1%
4/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Investigations
Platelet count decreased
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Nervous system disorders
Syncope
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
3/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
2/36 • From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
The study protocol required reporting of grade\>=3 signs/symptoms, grade\>=3 laboratory events and all signs/symptoms and laboratory events that lead to a change in study treatment, as well as diagnoses identified by the ACTG criteria for clinical events and other diseases. See DAIDS AE Grading Table (V1.0), December 2004 (Clarification, August 2009) and EAE manual (V2.0). All participants who initiated study treatment were included.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
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