Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01797445
First received: February 20, 2013
Last updated: December 4, 2015
Last verified: December 2015
Results First Received: December 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Interventions: Drug: E/C/F/TAF
Drug: E/C/F/TDF
Drug: E/C/F/TDF Placebo
Drug: E/C/F/TAF Placebo

  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 study sites in North America and Europe. The first participant was screened on 12 March 2013. The last Week 96 study visit occurred on 03 August 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1070 participants were screened.

Reporting Groups
  Description
E/C/F/TAF Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Participant Flow:   Overall Study
    E/C/F/TAF     E/C/F/TDF  
STARTED     435     437  
COMPLETED     0     0  
NOT COMPLETED     435     437  
Randomized but Not Treated                 4                 2  
Adverse Event                 3                 0  
Death                 1                 2  
Lack of Efficacy                 1                 2  
Investigator's Discretion                 8                 12  
Noncompliance with Study Drug                 3                 1  
Protocol Violation                 0                 1  
Withdrew Consent                 12                 19  
Lost to Follow-up                 22                 15  
Still on Study                 381                 383  



  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
E/C/F/TAF E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Total Total of all reporting groups

Baseline Measures
    E/C/F/TAF     E/C/F/TDF     Total  
Number of Participants  
[units: participants]
  431     435     866  
Age  
[units: years]
Mean (Standard Deviation)
  35  (10.8)     36  (10.9)     36  (10.9)  
Gender  
[units: participants]
     
Female     62     71     133  
Male     369     364     733  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     1     3     4  
Asian     15     12     27  
Black     129     132     261  
Native Hawaiian or Pacific Islander     4     1     5  
White     235     243     478  
Other     47     44     91  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     107     97     204  
Not Hispanic or Latino     323     336     659  
Not Permitted     1     1     2  
Missing     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     280     282     562  
United Kingdom     25     31     56  
Portugal     21     16     37  
Canada     19     22     41  
Netherlands     6     8     14  
Sweden     8     3     11  
Dominican Republic     30     35     65  
Italy     10     8     18  
Mexico     16     12     28  
France     16     18     34  
HIV-1 RNA  
[units: log10┬ácopies/mL]
Mean (Standard Deviation)
  4.53  (0.647)     4.50  (0.690)     4.52  (0.669)  
HIV-1 RNA Category  
[units: participants]
     
≤ 100,000 copies/mL     339     336     675  
> 100,000 to ≤ 400,000 copies/mL     68     82     150  
> 400,000 copies/mL     24     17     41  
CD4 Cell Count  
[units: /µL]
Mean (Standard Deviation)
  414  (206.8)     431  (226.8)     423  (217.1)  
CD4 Cell Count Category  
[units: participants]
     
< 50 cells/μL     14     15     29  
≥ 50 to < 200 cells/μL     40     49     89  
≥ 200 to < 350 cells/μL     115     89     204  
≥ 350 to < 500 cells/μL     134     149     283  
≥ 500 cells/μL     127     133     260  
Missing     1     0     1  
HIV Disease Status  
[units: participants]
     
Asymptomatic     377     394     771  
Symptomatic HIV Infection     30     19     49  
AIDS     22     19     41  
Unknown     2     3     5  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96   [ Time Frame: Week 96 ]

3.  Secondary:   Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96   [ Time Frame: Weeks 48 and 96 ]

4.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 48   [ Time Frame: Baseline; Week 48 ]

5.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 96   [ Time Frame: Baseline; Week 96 ]

6.  Secondary:   Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48   [ Time Frame: Baseline; Week 48 ]

7.  Secondary:   Percent Change From Baseline in Hip BMD at Week 96   [ Time Frame: Baseline; Week 96 ]

8.  Secondary:   Percent Change From Baseline in Spine BMD at Week 48   [ Time Frame: Baseline; Week 48 ]

9.  Secondary:   Percent Change From Baseline in Spine BMD at Week 96   [ Time Frame: Baseline; Week 96 ]

10.  Secondary:   Change From Baseline in Serum Creatinine at Week 48   [ Time Frame: Baseline; Week 48 ]

11.  Secondary:   Change From Baseline in Serum Creatinine at Week 96   [ Time Frame: Baseline; Week 96 ]

12.  Secondary:   Percentage of Participants With Treatment-emergent Proteinuria Through Week 48   [ Time Frame: Up to 48 weeks ]

13.  Secondary:   Percentage of Participants With Treatment-emergent Proteinuria Through Week 96   [ Time Frame: Up to 96 weeks ]

14.  Secondary:   Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48   [ Time Frame: Baseline; Week 48 ]

15.  Secondary:   Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96   [ Time Frame: Baseline; Week 96 ]

16.  Secondary:   Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48   [ Time Frame: Baseline; Week 48 ]

17.  Secondary:   Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96   [ Time Frame: Baseline; Week 96 ]


  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
There were no limitations affecting the analysis or results.


  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
e-mail: ClinicalTrialDisclosures@gilead.com


Publications of Results:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01797445     History of Changes
Other Study ID Numbers: GS-US-292-0111
2013-000102-37 ( EudraCT Number )
Study First Received: February 20, 2013
Results First Received: December 4, 2015
Last Updated: December 4, 2015
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Austria: Austrian Medicines and Medical Devices Agency
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Netherlands: Medicines Evaluation Board (MEB)
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Dominican Republic: Consejo Nacional de Bioetica en Salud
Mexico: Federal Commission for Protection Against Health Risks