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Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02121795
First received: April 22, 2014
Last updated: October 7, 2016
Last verified: October 2016
Results First Received: August 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV-1 Infection
Interventions: Drug: FTC/TDF
Drug: F/TAF
Drug: Allowed third antiretroviral agent
Drug: FTC/TDF Placebo
Drug: 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 8 May 2014. The last Week 48 study visit occurred on 12 August 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
780 participants were screened.

Reporting Groups
  Description
F/TAF + 3rd Agent Emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks
FTC/TDF + 3rd Agent FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks

Participant Flow:   Overall Study
    F/TAF + 3rd Agent   FTC/TDF + 3rd Agent
STARTED   334   334 
COMPLETED   0   0 
NOT COMPLETED   334   334 
Randomized but Never Treated                1                4 
Adverse Event                4                0 
Investigator's Discretion                1                0 
Non-Compliance with Study Drug                1                1 
Protocol Violation                0                2 
Withdrew Consent                10                10 
Lost to Follow-up                2                1 
Still in Study up to the Data Cut Date                315                316 



  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: all randomized participants who received at least one dose of study drug.

Reporting Groups
  Description
F/TAF + 3rd Agent F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
FTC/TDF + 3rd Agent FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
Total Total of all reporting groups

Baseline Measures
   F/TAF + 3rd Agent   FTC/TDF + 3rd Agent   Total 
Overall Participants Analyzed 
[Units: Participants]
 333   330   663 
Age 
[Units: Years]
Mean (Standard Deviation)
 47  (9.9)   48  (9.7)   48  (9.8) 
Gender 
[Units: Participants]
     
Female   48   54   102 
Male   285   276   561 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   48   78   126 
Not Hispanic or Latino   285   252   537 
Unknown or Not Reported   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   2   1   3 
Asian   6   0   6 
Black   69   67   136 
Native Hawaiian or Pacific Islander   2   1   3 
White   244   253   497 
Not Permitted   1   1   2 
Other   9   7   16 
Region of Enrollment 
[Units: Participants]
     
Canada   5   9   14 
Belgium   3   3   6 
United States   282   274   556 
Italy   2   6   8 
United Kingdom   23   17   40 
France   18   21   39 
Baseline Third Agent 
[Units: Participants]
     
Atazanavir boosted with ritonavir (ATV/r)   53   50   103 
Darunavir boosted with ritonavir (DRV/r)   84   82   166 
Lopinavir boosted with ritonavir (LPV/r)   18   18   36 
Dolutegravir (DTG)   26   23   49 
Efavirenz (EFV)   8   6   14 
Maraviroc (MVC)   1   6   7 
Nevirapine (NVP)   74   66   140 
Raltegravir (RAL)   66   73   139 
Rilpivirine (RPV)   3   6   9 
HIV-1 RNA Categories 
[Units: Participants]
     
< 50 copies/mL   329   326   655 
>= 50 copies/mL   4   4   8 
CD4 Cell Count 
[Units: cells/µL]
Mean (Standard Deviation)
 691  (272.6)   667  (272.3)   679  (272.5) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis   [ 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:   Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis   [ Time Frame: Week 48 ]

5.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 48   [ Time Frame: Baseline; Week 48 ]

6.  Secondary:   Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis   [ Time Frame: Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis   [ Time Frame: Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Percent Change From Baseline in Hip and Spine BMD at Week 96   [ Time Frame: Baseline; Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 96   [ Time Frame: Baseline; Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02121795     History of Changes
Other Study ID Numbers: GS-US-311-1089
2013-005138-39 ( EudraCT Number )
Study First Received: April 22, 2014
Results First Received: August 11, 2016
Last Updated: October 7, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
European Union: European Medicines Agency
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Belgium: Federal Agency for Medicines and Health Products, FAMHP