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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
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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
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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 ]
  Hide Outcome Measure 9

Measure Type Secondary
Measure Title Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24
Measure Description The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.
Time Frame Baseline to Week 24  
Safety Issue No  

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 who had measurements for direct LDL cholesterol at both baseline and Week 24 were analyzed.

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.

Measured Values
   FTC/RPV/TDF   SBR/Delayed Switch 
Participants Analyzed 
[Units: Participants]
 270   134 
Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24 
[Units: mg/dL]
Mean (Standard Deviation)
 -16  (25.6)   0  (23.7) 

No statistical analysis provided for Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through 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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