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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


  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 ]

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