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FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir

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ClinicalTrials.gov Identifier: NCT01777997
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Intervention Drug: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Enrollment 38

Recruitment Details Recruited at 19 Clinical Research Sites (CRSs) in the United States between April 25, 2013 and December 22, 2014.
Pre-assignment Details  
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description

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.

Period Title: 12 Week lead-in of no ART
Started 38
Completed 36
Not Completed 2
Reason Not Completed
Severe debilitation             2
Period Title: Weeks 0 to 24/48 on ART
Started 36
Completed 35 [1]
Not Completed 1
Reason Not Completed
Participant felt treatment not working             1
[1]
7 of these participants opted not to continue ART into next period
Period Title: Weeks 48 to 72/96 on ART
Started 28
Completed 26
Not Completed 2
Reason Not Completed
Death             1
Took prohibited/precautionary meds             1
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
Participants who were on intervention (ART) for at least 24 weeks
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 35 participants
47
(32 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
15
  42.9%
Male
20
  57.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants
White non-Hispanic 6
Black non-Hispanic 26
Hispanic (regardless of race) 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
CD4+ T-cell count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 35 participants
682
(564 to 1003)
[1]
Measure Description: Baseline CD4+ T-cell count is the mean of the two measurements obtained prior to the start of ART (study entry and study week 12).
HIV-1 RNA by Abbott Assay  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Pre-ART (study entry) <40 copies/mL
16
  45.7%
>=40 copies/mL
19
  54.3%
Week 0 on ART (study week 12) <40 copies/mL
13
  37.1%
>=40 copies/mL
22
  62.9%
Percentage of CD8+ T-cells that are CD38+HLA-DR+   [1] 
Median (Inter-Quartile Range)
Unit of measure:  % of CD8+ T-cells
Number Analyzed 35 participants
24.6
(19.6 to 33.4)
[1]
Measure Description: Baseline CD8+ T-cell activation is the mean of the two measurements obtained prior to the start of ART (study entry and study week 12).
Percentage of CD4+ T-cells that are CD38+HLA-DR+   [1] 
Median (Inter-Quartile Range)
Unit of measure:  % of CD4+ T-cells
Number Analyzed 35 participants
2.6
(2.2 to 4.1)
[1]
Measure Description: Baseline CD4+ T-cell activation is the mean of the two measurements obtained prior to the start of ART (study entry and study week 12).
Interleukin (IL)-6   [1] 
Median (Inter-Quartile Range)
Unit of measure:  log10(pg/mL)
Number Analyzed 35 participants
0.17
(0.08 to 0.38)
[1]
Measure Description: Baseline IL-6 is the mean of the two log10-transformed measurements obtained prior to the start of ART (study entry and study week 12).
D-dimer   [1] 
Median (Inter-Quartile Range)
Unit of measure:  log10(ng/mL)
Number Analyzed 35 participants
2.58
(2.39 to 2.82)
[1]
Measure Description: Baseline D-dimer is the mean of the two log10-transformed measurements obtained prior to the start of ART (study entry and study week 12).
Quality of life (QoL) index   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 35 participants
0.2
(0.1 to 0.3)
[1]
Measure Description: 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". Baseline QoL index is the mean of the two averages obtained prior to the start of ART (study entry and study week 12).
1.Primary Outcome
Title Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART
Hide Description 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)
Time Frame From baseline (pre-ART and week 0 on ART) to weeks 24 and 48 on ART
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Mean (95% Confidence Interval)
Unit of Measure: % of CD8+ T-cells
-4.01
(-6.41 to -1.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF
Comments Estimated mean change from baseline to weeks 24-48 on ART from repeated measures (GEE) model, against the null hypothesis of zero change. Estimated mean represents on ART levels minus pre-ART levels.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, repeated measures (GEE)
Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description At a specific week, the proportion of participants with HIV-1 RNA by iSCA less than assay limit of detection (0.6 copies/mL)
Time Frame At pre-ART and weeks 0, 4, 12, 24, 36 and 48 on ART
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: proportion of participants
Pre-ART Number Analyzed 31 participants
0.19
Week 0 on ART Number Analyzed 31 participants
0.19
Week 4 on ART Number Analyzed 28 participants
0.61
Week 12 on ART Number Analyzed 30 participants
0.90
Week 24 on ART Number Analyzed 30 participants
0.93
Week 36 on ART Number Analyzed 26 participants
0.92
Week 48 on ART Number Analyzed 24 participants
0.96
3.Secondary Outcome
Title Change in CD4+ T-cell Count
Hide Description 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)
Time Frame From baseline (pre-ART and week 0 on ART) to weeks 12, 24, 36 and 48 on ART
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Week 12 on ART Number Analyzed 33 participants
-15
(-124 to 64)
Week 24 on ART Number Analyzed 33 participants
-5
(-112 to 68)
Week 36 on ART Number Analyzed 30 participants
25
(-43 to 154)
Week 48 on ART Number Analyzed 29 participants
19
(-108 to 103)
4.Secondary Outcome
Title Change in Levels of CD8+ T-cell Activation
Hide Description Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART)
Time Frame From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Median (Inter-Quartile Range)
Unit of Measure: % of CD8+ T-cells
Week 4 on ART Number Analyzed 33 participants
-0.7
(-4.7 to 4.2)
Week 12 on ART Number Analyzed 34 participants
-1.6
(-6.2 to 4.5)
Week 24 on ART Number Analyzed 33 participants
-2.2
(-6.1 to 0)
Week 48 on ART Number Analyzed 29 participants
-4.7
(-7.4 to 0.3)
5.Secondary Outcome
Title Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)
Hide Description Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART)
Time Frame From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Median (Inter-Quartile Range)
Unit of Measure: % of CD4+ T-cells
Week 4 on ART Number Analyzed 33 participants
0.1
(-0.6 to 1.0)
Week 12 on ART Number Analyzed 34 participants
-0.1
(-0.4 to 0.7)
Week 24 on ART Number Analyzed 33 participants
-0.2
(-0.8 to 0.1)
Week 48 on ART Number Analyzed 29 participants
-0.2
(-0.9 to 0.4)
6.Secondary Outcome
Title Change in Levels of Interleukin (IL)-6
Hide Description 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)
Time Frame From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Median (Inter-Quartile Range)
Unit of Measure: log10(pg/mL)
Week 4 on ART Number Analyzed 33 participants
0.05
(-0.07 to 0.16)
Week 12 on ART Number Analyzed 33 participants
0.01
(-0.14 to 0.15)
Week 24 on ART Number Analyzed 32 participants
0.02
(-0.06 to 0.18)
Week 48 on ART Number Analyzed 27 participants
0
(-0.14 to 0.14)
7.Secondary Outcome
Title Change in Levels of D-dimer
Hide Description 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)
Time Frame From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Median (Inter-Quartile Range)
Unit of Measure: log10(ng/mL)
Week 4 on ART Number Analyzed 31 participants
0.01
(-0.12 to 0.16)
Week 24 on ART Number Analyzed 32 participants
0.01
(-0.19 to 0.30)
Week 48 on ART Number Analyzed 27 participants
0.02
(-0.20 to 0.26)
8.Secondary Outcome
Title Change in Quality of Life (QoL) Index
Hide Description 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)
Time Frame From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Week 4 on ART Number Analyzed 33 participants
0
(-0.1 to 0)
Week 24 on ART Number Analyzed 34 participants
-0.1
(-0.2 to 0)
Week 48 on ART Number Analyzed 29 participants
0
(-0.1 to 0)
9.Secondary Outcome
Title Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated ART, regardless of ART status at time of event
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
18
Time Frame From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
Adverse Event Reporting Description 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.
 
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description

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.

All-Cause Mortality
FTC/RPV/TDF
Affected / at Risk (%)
Total   1/36 (2.78%) 
Show Serious Adverse Events Hide Serious Adverse Events
FTC/RPV/TDF
Affected / at Risk (%)
Total   1/36 (2.78%) 
Infections and infestations   
Bronchitis  1  1/36 (2.78%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FTC/RPV/TDF
Affected / at Risk (%)
Total   23/36 (63.89%) 
Eye disorders   
Eye pruritus  1  2/36 (5.56%) 
Gastrointestinal disorders   
Abdominal pain upper  1  3/36 (8.33%) 
Diarrhoea  1  3/36 (8.33%) 
Nausea  1  4/36 (11.11%) 
Proctalgia  1  2/36 (5.56%) 
Vomiting  1  4/36 (11.11%) 
General disorders   
Fatigue  1  2/36 (5.56%) 
Peripheral swelling  1  2/36 (5.56%) 
Pyrexia  1  2/36 (5.56%) 
Infections and infestations   
Acarodermatitis  1  2/36 (5.56%) 
Bacterial vaginosis  1  3/36 (8.33%) 
Investigations   
Alanine aminotransferase increased  1  5/36 (13.89%) 
Aspartate aminotransferase increased  1  4/36 (11.11%) 
Blood bilirubin increased  1  3/36 (8.33%) 
Blood creatinine increased  1  3/36 (8.33%) 
Blood glucose increased  1  2/36 (5.56%) 
Blood phosphorus decreased  1  5/36 (13.89%) 
Blood sodium decreased  1  5/36 (13.89%) 
Neutrophil count decreased  1  4/36 (11.11%) 
Platelet count decreased  1  2/36 (5.56%) 
Metabolism and nutrition disorders   
Decreased appetite  1  3/36 (8.33%) 
Nervous system disorders   
Syncope  1  2/36 (5.56%) 
Reproductive system and breast disorders   
Vaginal discharge  1  3/36 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  3/36 (8.33%) 
Nasal congestion  1  3/36 (8.33%) 
Oropharyngeal pain  1  3/36 (8.33%) 
Productive cough  1  3/36 (8.33%) 
Skin and subcutaneous tissue disorders   
Erythema  1  2/36 (5.56%) 
Pruritus  1  2/36 (5.56%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01777997     History of Changes
Other Study ID Numbers: ACTG A5308
1U01AI068636 ( U.S. NIH Grant/Contract )
First Submitted: January 10, 2013
First Posted: January 29, 2013
Results First Submitted: October 31, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018