Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01309243
First received: March 3, 2011
Last updated: February 3, 2015
Last verified: February 2015
Results First Received: September 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infection
Interventions: Drug: FTC/RPV/TDF
Drug: EFV/FTC/TDF

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) were analyzed for baseline characteristics.

Reporting Groups
  Description
FTC/RPV/TDF FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV/FTC/TDF EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Total Total of all reporting groups

Baseline Measures
    FTC/RPV/TDF     EFV/FTC/TDF     Total  
Number of Participants  
[units: participants]
  394     392     786  
Age  
[units: years]
Mean ± Standard Deviation
  37  ± 10.4     37  ± 11.0     37  ± 10.7  
Gender  
[units: participants]
     
Female     28     28     56  
Male     366     364     730  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     3     1     4  
Asian     8     13     21  
Black or African Heritage     98     94     192  
Native Hawaiian or Pacific Islander     4     3     7  
White     266     262     528  
Other     13     19     32  
Not Permitted     1     0     1  
Not Reported     1     0     1  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic/Latino     59     75     134  
Non-Hispanic/Latino     331     315     646  
Not Permitted     3     2     5  
Not Reported     1     0     1  
Region of Enrollment [1]
[units: participants]
     
United States     262     279     541  
Australia     15     25     40  
Canada     28     20     48  
Germany     25     22     47  
France     16     7     23  
United Kingdom     12     8     20  
Puerto Rico     8     10     18  
Spain     9     6     15  
Italy     10     3     13  
Belgium     4     5     9  
Portugal     2     5     7  
Switzerland     2     3     5  
Austria     7     6     13  
HIV-1 RNA  
[units: log10┬ácopies/mL]
Mean ± Standard Deviation
  4.8  ± 0.65     4.8  ± 0.61     4.8  ± 0.63  
HIV-1 RNA Category  
[units: participants]
     
≤ 100,000 copies/mL     260     250     510  
> 100,000 copies/mL     134     142     276  
Cluster of differentiation 4 (CD4) Cell Count  
[units: cells/μL]
Mean ± Standard Deviation
  395.7  ± 179.64     385.2  ± 186.82     390.5  ± 183.21  
Use of lipid-lowering agent  
[units: participants]
     
Yes     4     1     5  
No     390     391     781  
[1] All randomized participants were analyzed for Region of Enrollment



  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96   [ Time Frame: Baseline to Week 96 ]

3.  Secondary:   Change From Baseline in CD4 Cell Count at Week 48   [ Time Frame: Baseline to Week 48 ]

4.  Secondary:   Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline to Week 96 ]

5.  Secondary:   Change From Baseline in Fasting Total Cholesterol at Week 48   [ Time Frame: Baseline to Week 48 ]

6.  Secondary:   Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48   [ Time Frame: Baseline to Week 48 ]

7.  Secondary:   Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48   [ Time Frame: Baseline to Week 48 ]

8.  Secondary:   Change From Baseline in Fasting Triglycerides at Week 48   [ Time Frame: Baseline to Week 48 ]

9.  Secondary:   Development of HIV-1 Drug Resistance Through Week 96, All Participants   [ Time Frame: Baseline to Week 96 ]

10.  Secondary:   Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance   [ Time Frame: Baseline to Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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