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Trial record 1 of 1 for:    GS-US-292-0104
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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:
NCT01780506
First received: January 16, 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, Europe, and Asia. The first participant was screened on 26 December 2012. The last Week 96 study visit occurred on 31 July 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1105 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   438   434 
COMPLETED   0   0 
NOT COMPLETED   438   434 
Randomized but not Treated                3                2 
Adverse Event                3                8 
Death                0                1 
Pregnancy                1                0 
Lack of Efficacy                1                1 
Investigator's Discretion                2                1 
Non-Compliance with Study Drug                1                1 
Protocol Violation                3                3 
Withdrew Consent                13                15 
Lost to Follow-up                10                14 
Still on Study                401                388 



  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 were randomized and received at least 1 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]
 435   432   867 
Age 
[Units: Years]
Mean (Standard Deviation)
 35  (10.0)   36  (10.5)   35  (10.3) 
Gender 
[Units: Participants]
     
Female   71   56   127 
Male   364   376   740 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   60   70   130 
Not Hispanic or Latino   375   362   737 
Unknown or Not Reported   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   4   5   9 
Asian   76   77   153 
Black   94   81   175 
Native Hawaiian or Pacific Islander   1   3   4 
White   250   255   505 
Other   10   11   21 
Region of Enrollment 
[Units: Participants]
     
United States   252   250   502 
Japan   4   6   10 
United Kingdom   1   5   6 
Thailand   63   58   121 
Switzerland   6   12   18 
Spain   42   42   84 
Canada   23   23   46 
Austria   15   8   23 
Belgium   7   7   14 
Italy   3   6   9 
Australia   19   15   34 
HIV-1 RNA (log10 copies/mL) 
[Units: Log10 copies/mL]
Mean (Standard Deviation)
 4.55  (0.682)   4.55  (0.674)   4.55  (0.678) 
HIV-1 RNA Category 
[Units: Participants]
     
≤ 100,000   331   336   667 
> 100,000 to ≤ 400,000   79   72   151 
> 400,000   25   24   49 
CD4 Cell Count 
[Units: cells/µL]
Mean (Standard Deviation)
 437  (223.7)   426  (212.3)   432  (218.0) 
CD4 Cell Count Category 
[Units: Participants]
     
< 50   10   12   22 
≥ 50 to < 200   48   41   89 
≥ 200 to < 350   103   111   214 
≥ 350 to < 500   122   135   257 
≥ 500   152   133   285 
HIV Disease Status 
[Units: Participants]
     
Asymptomatic   402   406   808 
Symptomatic HIV Infection   23   15   38 
AIDS   9   10   19 
Unknown   1   1   2 


  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:   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 Experiencing Treatment-emergent Proteinuria Through Week 48   [ Time Frame: Up to 48 weeks ]

13.  Secondary:   Percentage of Participants Experiencing 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: NCT01780506     History of Changes
Other Study ID Numbers: GS-US-292-0104
2012-004458-27 ( EudraCT Number )
Study First Received: January 16, 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
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Netherlands: Medicines Evaluation Board (MEB)
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Thailand: Food and Drug Administration
Austria: Federal Office for Safety in Health Care