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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01497899
First received: December 14, 2011
Last updated: September 8, 2016
Last verified: September 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: Acquired Immunodeficiency Syndrome
HIV Infections
Interventions: Drug: E/C/F/TDF
Drug: E/C/F/TAF Placebo
Drug: E/C/F/TAF
Drug: E/C/F/TDF 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 the United States and Puerto Rico. The first participant was screened on 28 December 2011. The last Week 96 study visit occurred on 07 March 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
232 participants were screened for the Double-Blind Phase. 108 participants from other Gilead-sponsored studies joined the Open-Label Extension Phase.

Reporting Groups
  Description
E/C/F/TAF

Double-Blind Phase: 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 48 weeks

Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

E/C/F/TDF

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

D/C/F/TAF to Open-Label E/C/F/TAF Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
DRV+COBI+TVD to Open-Label E/C/F/TAF Participants previously received darunavir (DRV) + cobicistat (COBI) + truvada (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.

Participant Flow for 2 periods

Period 1:   Double-Blind Phase
    E/C/F/TAF   E/C/F/TDF   D/C/F/TAF to Open-Label E/C/F/TAF   DRV+COBI+TVD to Open-Label E/C/F/TAF
STARTED   113   58   0   0 
COMPLETED   107   53   0   0 
NOT COMPLETED   6   5   0   0 
Randomized but not Treated                1                0                0                0 
Adverse Event                1                0                0                0 
Lack of Efficacy                0                1                0                0 
Investigator's Discretion                1                0                0                0 
Withdrew Consent                0                1                0                0 
Lost to Follow-up                3                2                0                0 
Subject Non-Compliance                0                1                0                0 

Period 2:   Open-Label Extension Phase
    E/C/F/TAF   E/C/F/TDF   D/C/F/TAF to Open-Label E/C/F/TAF   DRV+COBI+TVD to Open-Label E/C/F/TAF
STARTED   105 [1]   53   70 [2]   38 [2] 
COMPLETED   0   0   0   0 
NOT COMPLETED   105   53   70   38 
Lost to Follow-up                1                0                1                0 
Still in the Open-Label Extension Phase                104                53                69                38 
[1] 2 participants completed the Double-Blind Phase, but did not continue in the Open-Label Extension.
[2] Participants enrolled from other Gilead-sponsored studies.



  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.

E/C/F/TAF and E/C/F/TDF arms: participants who were randomized to the Double-Blind Phase and received at least 1 dose of study drug.

D/C/F/TAF to E/C/F/TAF and DRV+COBI+TVD to E/C/F/TAF arms: participants who enrolled from other Gilead-sponsored studies into the Open-Label Extension Phase and received at least 1 dose of open-label E/C/F/TAF.


Reporting Groups
  Description
E/C/F/TAF

Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks

Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

E/C/F/TDF

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

D/C/F/TAF to Open-Label E/C/F/TAF Participants previously received D/C/F/TAF in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
DRV+COBI+TVD to Open-Label E/C/F/TAF Participants previously received DRV+COBI+TVD in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
Total Total of all reporting groups

Baseline Measures
   E/C/F/TAF   E/C/F/TDF   D/C/F/TAF to Open-Label E/C/F/TAF   DRV+COBI+TVD to Open-Label E/C/F/TAF   Total 
Overall Participants Analyzed 
[Units: Participants]
 112   58   70   38   278 
Age 
[Units: Years]
Mean (Standard Deviation)
 35  (11.3)   37  (10.6)   36  (11.2)   37  (10.7)   36  (11.0) 
Gender 
[Units: Participants]
         
Female   4   1   3   3   11 
Male   108   57   67   35   267 


  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24   [ Time Frame: Week 24 ]

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

3.  Secondary:   Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48   [ Time Frame: Baseline; Weeks 24 and 48 ]

4.  Secondary:   Change From Baseline in CD4+ Cell Count at Weeks 24 and 48   [ Time Frame: Baseline; Weeks 24 and 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
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: NCT01497899     History of Changes
Other Study ID Numbers: GS-US-292-0102
Study First Received: December 14, 2011
Results First Received: December 4, 2015
Last Updated: September 8, 2016
Health Authority: United States: Food and Drug Administration