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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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled in a total of 121 study sites in North America, Europe, and Australia. The first participant was screened on 23 February 2011. The last participant observation was on 03 February 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
991 participants were screened.

Reporting Groups
  Description
FTC/RPV/TDF Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily
EFV/FTC/TDF Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily

Participant Flow for 2 periods

Period 1:   Randomized Phase Through Week 96
    FTC/RPV/TDF   EFV/FTC/TDF
STARTED   400   399 
Randomized and Treated   394   392 
COMPLETED   316   290 
NOT COMPLETED   84   109 
Randomized but not treated                6                7 
Adverse Event                12                43 
Death                0                1 
Pregnancy                2                0 
Lack of Efficacy                16                4 
Investigators Discretion                3                6 
Withdrew Consent                12                18 
Lost to Follow-up                23                22 
Subject Non-Compliance                9                7 
Protocol Violation                1                1 

Period 2:   Extension Phase
    FTC/RPV/TDF   EFV/FTC/TDF
STARTED   40 [1]   117 [2] 
COMPLETED   34   117 
NOT COMPLETED   6   0 
Lost to Follow-up                6                0 
[1] 40 participants from the Randomized Phase continued the study in the Extension Phase.
[2] 117 participants from the Randomized Phase continued the study in the Extension Phase.



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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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  More Information