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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


  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.
Safety Analysis Set: participants who were randomized and received at least one dose of study drug

Reporting Groups
  Description
FTC/RPV/TDF Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF 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.
Total Total of all reporting groups

Baseline Measures
   FTC/RPV/TDF   SBR/Delayed Switch   Total 
Overall Participants Analyzed 
[Units: Participants]
 317   159   476 
Age 
[Units: Years]
Mean (Standard Deviation)
 41  (9.2)   43  (9.7)   42  (9.4) 
Gender 
[Units: Participants]
     
Female   44   15   59 
Male   273   144   417 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   51   31   82 
Not Hispanic or Latino   264   128   392 
Unknown or Not Reported   2   0   2 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   241   124   365 
Black or African American   61   22   83 
American Indian or Alaska Native   3   2   5 
Asian   6   2   8 
Other   6   9   15 
Region of Enrollment [1] 
[Units: Participants]
     
Austria   18   8   26 
Belgium   15   13   28 
Canada   15   10   25 
France   29   14   43 
Germany   31   12   43 
Italy   16   10   26 
Puerto Rico   16   2   18 
Spain   15   5   20 
United Kingdom   17   6   23 
United States   149   81   230 
[1] Four participants in the Switch to FTC/RPV/TDF group and 2 participants in the Stay on Baseline Regimen (SBR) group were randomized but were not treated. These subjects are included in the analysis of the baseline characteristic "Region of Enrollment" but are not included in the analysis of other baseline characteristics.
Baseline HIV-1 RNA Category 
[Units: Participants]
     
< 50 Copies/mL   299   152   451 
50 to < 200 Copies/mL   10   6   16 
200 to < 400 Copies/mL   2   0   2 
400 to < 1000 Copies/mL   2   0   2 
≥ 1000 Copies/mL   4   1   5 
Stratification based on antiretroviral (ARV) use 
[Units: Participants]
     
TDF or FTC/TDF + lopinavir (LPV)/ritonavir (RTV)   82   49   131 
TDF or FTC/TDF + Other PI+RTV   178   81   259 
Non-TDF-containing regimen + LPV/RTV   15   9   24 
Non-TDF-containing regimen + Other PI+RTV   42   20   62 


  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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