Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase 3b Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination 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:
NCT01475838
First received: November 17, 2011
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: January 8, 2015  
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: RTV
Drug: FTC/TDF
Drug: PI

  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 86 study sites in North America and Europe. The first participant was screened on 18 November 2011. The last Week 48 study visit occurred on 18 November 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
632 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 Stribild® (Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR)) once daily for 96 weeks
PI+RTV+FTC/TDF Ritonavir (RTV 100 mg)-boosted protease inhibitor (PI)+FTC 200 mg/TDF 300 mg for 96 weeks; PI may have been atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV), administered according to prescribing information.

Participant Flow:   Overall Study
    Stribild     PI+RTV+FTC/TDF  
STARTED     293     145  
COMPLETED     0     0  
NOT COMPLETED     293     145  
Randomized but Not Treated                 0                 5  
Adverse Event                 4                 0  
Pregnancy                 0                 1  
Investigators Discretion                 0                 2  
Withdrew Consent                 7                 9  
Lost to Follow-up                 3                 5  
Subject Noncompliance                 0                 3  
Protocol Violation                 9                 4  
Subject Still on Study Treatment                 270                 116  



  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 medication.

Reporting Groups
  Description
Stribild Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg STR) once daily for 96 weeks
PI+RTV+FTC/TDF PI+RTV 100 mg+FTC 200 mg/TDF 300 mg for 96 weeks; PI may have been ATV, DRV, FPV, LPV, or SQV, administered according to prescribing information.
Total Total of all reporting groups

Baseline Measures
    Stribild     PI+RTV+FTC/TDF     Total  
Number of Participants  
[units: participants]
  293     140     433  
Age  
[units: years]
Mean ± Standard Deviation
  41  ± 9.7     41  ± 8.9     41  ± 9.4  
Age, Customized  
[units: participants]
     
< 40 years     130     68     198  
≥ 40 to < 50 years     109     49     158  
≥ 50 years     54     23     77  
Gender  
[units: participants]
     
Female     43     19     62  
Male     250     121     371  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic/Latino     42     17     59  
NonHispanic/Latino     249     123     372  
Not Permitted     2     0     2  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     2     1     3  
Asian     7     2     9  
Black or African Heritage     43     20     63  
White     234     113     347  
Other     5     2     7  
Not Permitted     2     2     4  
Region of Enrollment  
[units: participants]
     
Portugal     12     7     19  
France     39     15     54  
United States     84     40     124  
Puerto Rico     3     2     5  
Canada     5     3     8  
Spain     28     21     49  
Belgium     6     2     8  
Austria     11     4     15  
Germany     36     21     57  
United Kingdom     13     1     14  
Switzerland     12     8     20  
Italy     44     16     60  
HIV-1 RNA Category  
[units: participants]
     
< 50 copies/mL     291     137     428  
50 to < 200 copies/mL     2     2     4  
200 to < 400 copies/mL     0     0     0  
≥ 400 copies/mL     0     1     1  
HIV Disease Status  
[units: participants]
     
Asymptomatic     214     105     319  
Symptomatic HIV Infections     38     17     55  
AIDS     41     18     59  
CD4 Cell Count  
[units: cells/µL]
Mean ± Standard Deviation
  604  ± 274.6     624  ± 269.9     610  ± 272.9  
CD4 Cell Count Category  
[units: participants]
     
≤ 50 cells/µL     0     0     0  
51 to ≤ 200 cells/µL     9     6     15  
201 to ≤ 350 cells/µL     37     14     51  
351 to ≤ 500 cells/µL     69     26     95  
> 500 cells/µL     178     94     272  



  Outcome Measures
  Show All Outcome Measures

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


Publications of Results:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01475838     History of Changes
Other Study ID Numbers: GS-US-236-0115, 2011-004483-30
Study First Received: November 17, 2011
Results First Received: January 8, 2015
Last Updated: January 22, 2015
Health Authority: United States: Food and Drug Administration