Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 31, 2014
Last verified: October 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
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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 This reporting group includes participants who switched from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Stay on Baseline Regimen For the reporting of Baseline Characteristics, this group includes participants who stayed on their existing treatment regimen from the beginning of the study until Week 24, and who may have switched to the FTC/RPV/TDF STR at the Week 24 visit.
Total Total of all reporting groups

Baseline Measures
    FTC/RPV/TDF     Stay on Baseline Regimen     Total  
Number of Participants  
[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  
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  
[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.



  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 ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48
Measure Description The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed.
Time Frame Baseline to Week 48  
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 48 were analyzed.

Reporting Groups
  Description
FTC/RPV/TDF This reporting group includes participants who switched from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Delayed Switch to FTC/RPV/TDF This reporting group includes participants in the Stay on Baseline Regimen Group who switched to the FTC/RPV/TDF STR at the Week 24 visit.

Measured Values
    FTC/RPV/TDF     Delayed Switch to FTC/RPV/TDF  
Number of Participants Analyzed  
[units: participants]
  265     139  
Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48  
[units: mg/dL]
Mean ± Standard Deviation
  -16  ± 27.1     -14  ± 26.8  

No statistical analysis provided for Change From Baseline in Fasting Direct LDL Cholesterol Through 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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