Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01495702
First received: December 14, 2011
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: December 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Interventions: Drug: Stribild
Drug: FTC/TDF
Drug: NNRTI

  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 a total of 73 study sites in North America, Europe, and Australia. The first participant was screened on 13 December 2011. The last Week 48 study visit occurred on 14 November 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
571 participants were screened. Data submitted represent interim analysis performed on data collected by the Primary Completion Date, Nov 2013. Complete data will be submitted in December 2015.

Reporting Groups
  Description
Stribild Participants switched from their baseline treatment regimen to Stribild (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regiment (STR) once daily for 96 weeks.
NNRTI+FTC/TDF Participants stayed on their baseline treatment regimen consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) administered according to prescribing information plus FTC 200 mg/TDF 300 mg for 96 weeks; allowed NNRTIs included efavirenz (EFV), nevapirine (NVP), or rilpivirine (RPV).

Participant Flow:   Overall Study
    Stribild     NNRTI+FTC/TDF  
STARTED     292     147  
COMPLETED     0     0  
NOT COMPLETED     292     147  
Randomized But Not Treated                 1                 4  
Adverse Event                 1                 0  
Death                 1                 0  
Investigators Discretion                 2                 0  
Withdrew Consent                 9                 14  
Lost to Follow-up                 1                 2  
Protocol Violation                 3                 1  
Subject Still On Study                 274                 126  



  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 were randomized and received at least one dose of study drug

Reporting Groups
  Description
Stribild Participants switched from their baseline treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 96 weeks.
NNRTI+FTC/TDF Participants stayed on their baseline treatment regimen consisting of an NNRTI administered according to prescribing information plus FTC 200 mg/TDF 300 mg for 96 weeks; allowed NNRTIs included EFV, NVP, or RPV.
Total Total of all reporting groups

Baseline Measures
    Stribild     NNRTI+FTC/TDF     Total  
Number of Participants  
[units: participants]
  291     143     434  
Age  
[units: years]
Mean ± Standard Deviation
  42  ± 9.6     40  ± 9.7     41  ± 9.7  
Gender  
[units: participants]
     
Female     23     9     32  
Male     268     134     402  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     30     16     46  
Not Hispanic or Latino     261     127     388  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     4     9     13  
Black or African Heritage     49     23     72  
Native Hawaiian or Pacific Islander     1     0     1  
White     231     109     340  
Other     4     2     6  
Region of Enrollment  
[units: participants]
     
France     4     1     5  
Portugal     2     4     6  
United States     152     75     227  
Puerto Rico     4     2     6  
Canada     13     6     19  
Spain     27     13     40  
Belgium     14     7     21  
Austria     6     3     9  
Australia     8     4     12  
Germany     24     10     34  
United Kingdom     13     5     18  
Italy     24     13     37  
HIV-1 RNA Category  
[units: participants]
     
< 50 copies/mL     285     141     426  
50 to < 200 copies/mL     4     2     6  
200 to < 400 copies/mL     0     0     0  
≥ 400 copies/mL     2     0     2  
CD4 Cell Count  
[units: cells/µL]
Mean ± Standard Deviation
  586  ± 210.3     593  ± 224.6     588  ± 214.9  
HIV Disease Status  
[units: participants]
     
Asymptomatic     225     115     340  
Symptomatic HIV Infections     36     14     50  
AIDS     30     14     44  



  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 48   [ Time Frame: Baseline; 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 by Gilead Sciences

Publications automatically indexed to this study:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01495702     History of Changes
Other Study ID Numbers: GS-US-236-0121, 2011-004963-56
Study First Received: December 14, 2011
Results First Received: December 31, 2014
Last Updated: January 22, 2015
Health Authority: United States: Food and Drug Administration