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Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01815736
First received: March 19, 2013
Last updated: March 15, 2016
Last verified: March 2016
Results First Received: March 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Interventions: Drug: E/C/F/TAF
Drug: E/C/F/TDF
Drug: EFV/FTC/TDF
Drug: RTV
Drug: ATV
Drug: FTC/TDF
Drug: COBI

  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, South America, Europe, Australia, and Thailand . The first participant was screened on 27 March 2013. The last Week 48 study visit occurred on 16 March 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1559 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) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
Stay on Baseline Treatment Regimen (SBR) Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.

Participant Flow:   Overall Study
    E/C/F/TAF     Stay on Baseline Treatment Regimen (SBR)  
STARTED     963     480  
COMPLETED     2     2  
NOT COMPLETED     961     478  
Randomized but Not Treated                 4                 3  
Adverse Event                 7                 4  
Death                 4                 0  
Investigator's Discretion                 4                 0  
Withdrew Consent                 7                 15  
Lost to Follow-up                 6                 7  
Still on Study                 929                 449  



  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 one dose of study drug

Reporting Groups
  Description
E/C/F/TAF E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
Stay on Baseline Treatment Regimen (SBR) Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
Total Total of all reporting groups

Baseline Measures
    E/C/F/TAF     Stay on Baseline Treatment Regimen (SBR)     Total  
Number of Participants  
[units: participants]
  959     477     1436  
Age  
[units: Years]
Mean (Standard Deviation)
  41  (10.1)     41  (10.1)     41  (10.1)  
Gender  
[units: participants]
     
Female     103     50     153  
Male     856     427     1283  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     5     2     7  
Asian     59     35     94  
Black     169     102     271  
Native Hawaiian or Pacific Islander     6     1     7  
White     651     314     965  
Not Permitted     2     1     3  
Other     67     22     89  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     248     82     330  
Not Hispanic or Latino     709     392     1101  
Not Permitted     2     3     5  
Region of Enrollment  
[units: participants]
     
United States     648     316     964  
United Kingdom     14     8     22  
Thailand     35     21     56  
Portugal     8     2     10  
Switzerland     5     4     9  
Spain     5     3     8  
Canada     51     27     78  
Austria     16     8     24  
Netherlands     2     3     5  
Sweden     1     0     1  
Belgium     14     8     22  
Brazil     14     5     19  
Denmark     1     2     3  
Dominican Republic     29     13     42  
Italy     13     6     19  
Mexico     19     6     25  
Australia     38     22     60  
France     12     12     24  
Germany     34     11     45  
HIV-1 RNA Category  
[units: participants]
     
< 50 copies/mL     943     466     1409  
≥ 50 copies/mL     16     11     27  



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

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

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

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

5.  Secondary:   Change From Baseline in Overall EFV-related Symptom Assessment Score at Week 48   [ Time Frame: Baseline; Week 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: NCT01815736     History of Changes
Other Study ID Numbers: GS-US-292-0109
2012-005114-20 ( EudraCT Number )
Study First Received: March 19, 2013
Results First Received: March 15, 2016
Last Updated: March 15, 2016
Health Authority: United States: Food and Drug Administration