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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: July 5, 2016
Last verified: July 2016
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 
Overall Participants Analyzed 
[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 copies/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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: July 5, 2016
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