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: 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, 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  
Number of Participants  
[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: 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
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