Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01252940
First received: December 1, 2010
Last updated: April 25, 2014
Last verified: April 2014
Results First Received: March 8, 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: PI
Drug: RTV
Drug: NRTIs

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 110 sites in the North America and Europe. The first participant was screened on 17 November 2010. The last participant observation for the Week 48 analysis was on 20 August 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
617 participants were screened and 482 were randomized. Of those participants randomized, 476 received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.

Reporting Groups
  Description
FTC/RPV/TDF This reporting group includes participants who switched from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
Stay on Baseline Regimen This reporting group includes participants who stayed on their existing treatment regimen at the beginning of the study through Week 24, and who may have switched at the Week 24 visit to the FTC/RPV/TDF STR through Week 48.

Participant Flow:   Overall Study
    FTC/RPV/TDF     Stay on Baseline Regimen  
STARTED     321     161  
Randomized and Treated     317     159  
Switched Regimen (Week 24 Visit)     0     152  
COMPLETED     294     146 [1]
NOT COMPLETED     27     15  
Randomized but not treated                 4                 2  
Adverse Event                 3                 4  
Lack of Efficacy                 1                 0  
Physician Decision                 1                 0  
Withdrawal by Subject                 7                 5  
Lost to Follow-up                 6                 1  
Subject Non-compliance                 1                 1  
Protocol Violation                 4                 2  
[1] Discontinuations after switch, withdrew from study, 2; adverse event, 4; protocol violation, 1.



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)   [ Time Frame: Week 48 ]

3.  Secondary:   Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:   Change From Baseline in CD4 Count Through Week 48   [ Time Frame: Baseline to Week 48 ]

5.  Secondary:   Change From Baseline in Fasting Total Cholesterol Through Week 24   [ Time Frame: Baseline to Week 24 ]

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

7.  Secondary:   Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24   [ Time Frame: Baseline to Week 24 ]

8.  Secondary:   Change From Baseline in Fasting HDL Cholesterol Through Week 48   [ Time Frame: Baseline to Week 48 ]

9.  Secondary:   Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24   [ Time Frame: Baseline to Week 24 ]

10.  Secondary:   Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48   [ Time Frame: Baseline to Week 48 ]

11.  Secondary:   Change From Baseline in Fasting Triglycerides Through Week 24   [ Time Frame: Baseline to Week 24 ]

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


  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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