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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01252940
First received: December 1, 2010
Last updated: October 27, 2015
Last verified: October 2015
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 was on 28 October 2014.

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

Reporting Groups
  Description
FTC/RPV/TDF Participants were randomized to switch 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.
SBR/Delayed Switch Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.

Participant Flow for 2 periods

Period 1:   Main Study Phase
    FTC/RPV/TDF     SBR/Delayed Switch  
STARTED     321     161  
Completed 24 Weeks     0     153 [1]
COMPLETED     295     149 [2]
NOT COMPLETED     26     12  
Randomized but not treated                 4                 2  
Adverse Event                 3                 1  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 6                 1  
Physician Decision                 1                 0  
Protocol Violation                 4                 2  
Withdrawal by Subject                 6                 5  
Subject Non-compliance                 1                 1  
[1] 152 participants switched regimens at Week 24.
[2] Discontinuations after switch: withdrawal by subject, 2; adverse event, 1; protocol violation, 1.

Period 2:   Extension Phase
    FTC/RPV/TDF     SBR/Delayed Switch  
STARTED     110 [1]   49 [2]
COMPLETED     100     46  
NOT COMPLETED     10     3  
Adverse Event                 2                 1  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 5                 0  
Physician Decision                 0                 1  
Subject Non-compliance                 1                 0  
Withdrawal by Subject                 1                 1  
[1] FTC/RPV/TDF group: 110 participants completing the main study continued in extension phase.
[2] SBR/Delayed Switch Group: 49 participants completing the main study continued in extension phase.



  Baseline Characteristics


  Outcome Measures
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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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