Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01286740
First received: January 27, 2011
Last updated: April 19, 2013
Last verified: April 2013
Results First Received: March 8, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infection
Intervention: Drug: FTC/RPV/TDF

  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 18 sites in the United States. The first participant was screened on 27 January 2011. The last participant observation was on 26 June 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
63 participants were screened, 50 were enrolled; 49 participants were treated, and comprise the Safety Analysis set. Participants in the Safety Analysis Set who had no major protocol violation comprise the Full Analysis Set.

Reporting Groups
  Description
FTC/RPV/TDF Participants switched from their existing treatment regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (tenofovir DF; TDF) to the FTC 200 mg/rilpivirine (RPV) 25 mg/TDF 300 mg single-table regimen (STR).

Participant Flow:   Overall Study
    FTC/RPV/TDF  
STARTED     50  
Enrolled and Treated     49  
Week 12 (Primary Endpoint)     49  
COMPLETED     48  
NOT COMPLETED     2  
Enrolled but not treated                 1  
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 enrolled and received at least one dose of study drug

Reporting Groups
  Description
FTC/RPV/TDF Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.

Baseline Measures
    FTC/RPV/TDF  
Number of Participants  
[units: participants]
  49  
Age  
[units: years]
Mean ± Standard Deviation
  38  ± 8.3  
Gender  
[units: participants]
 
Female     4  
Male     45  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     10  
Not Hispanic or Latino     39  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: participants]
 
White     40  
Black or African American     6  
Asian     3  
Baseline HIV-1 RNA Category  
[units: participants]
 
< 50 Copies/mL     47  
50 to < 400 Copies/mL     2  
EFV plasma concentration  
[units: ng/mL]
Mean ± Standard Deviation
  2204.9  ± 1059.42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)   [ Time Frame: Week 12 ]

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

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

4.  Secondary:   Plasma Concentration of RPV and EFV at Week 1   [ Time Frame: Week 1 ]

5.  Secondary:   Plasma Concentration of RPV and EFV at Week 2   [ Time Frame: Week 2 ]

6.  Secondary:   Plasma Concentration of RPV and EFV at Week 4   [ Time Frame: Week 4 ]

7.  Secondary:   Plasma Concentration of RPV and EFV at Week 6   [ Time Frame: Week 6 ]

8.  Secondary:   Plasma Concentration of RPV and EFV at Week 8   [ Time Frame: Week 8 ]

9.  Secondary:   Plasma Concentration of RPV at Week 12   [ Time Frame: Week 12 ]
  Hide Outcome Measure 9

Measure Type Secondary
Measure Title Plasma Concentration of RPV at Week 12
Measure Description The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.
Time Frame Week 12  
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 with measurements for plasma concentration of RPV at Week 12 were analyzed.

Reporting Groups
  Description
FTC/RPV/TDF Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.

Measured Values
    FTC/RPV/TDF  
Number of Participants Analyzed  
[units: participants]
  25  
Plasma Concentration of RPV at Week 12  
[units: ng/mL]
Mean ± Standard Deviation
  89.0  ± 54.13  

No statistical analysis provided for Plasma Concentration of RPV at Week 12



10.  Secondary:   Plasma Concentration of EFV at Week 12   [ Time Frame: Week 12 ]

11.  Secondary:   Plasma Concentration of RPV at Week 24   [ Time Frame: Week 24 ]

12.  Secondary:   Plasma Concentration of RPV at Week 36   [ Time Frame: Week 36 ]

13.  Secondary:   Plasma Concentration of RPV at Week 48   [ Time Frame: 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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01286740     History of Changes
Other Study ID Numbers: GS-US-264-0111
Study First Received: January 27, 2011
Results First Received: March 8, 2013
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration