D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01565850
First received: March 27, 2012
Last updated: March 11, 2016
Last verified: March 2016
Results First Received: March 11, 2016  
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: D/C/F/TAF
Drug: DRV
Drug: COBI
Drug: FTC/TDF
Drug: D/C/F/TAF Placebo
Drug: DRV Placebo
Drug: COBI Placebo
Drug: FTC/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 (including Puerto Rico). The first participant was screened on 16 April 2012. The last study visit occurred on 19 February 2014.

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

Reporting Groups
  Description
D/C/F/TAF Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) (800/150/200/10 mg) fixed-dose combination (FDC) tablet plus darunavir (DRV) placebo plus cobicistat (COBI) placebo plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily
DRV+COBI+FTC/TDF DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily

Participant Flow:   Overall Study
    D/C/F/TAF     DRV+COBI+FTC/TDF  
STARTED     103     50  
COMPLETED     83     42  
NOT COMPLETED     20     8  
Adverse Event                 0                 1  
Lost to Follow-up                 12                 4  
Investigator’s Discretion                 2                 1  
Participant noncompliance                 2                 0  
Withdrew Consent                 4                 2  



  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
D/C/F/TAF D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
DRV+COBI+FTC/TDF DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
Total Total of all reporting groups

Baseline Measures
    D/C/F/TAF     DRV+COBI+FTC/TDF     Total  
Number of Participants  
[units: participants]
  103     50     153  
Age  
[units: years]
Mean (Standard Deviation)
  35  (11.3)     37  (10.9)     35  (11.2)  
Gender  
[units: participants]
     
Female     8     3     11  
Male     95     47     142  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     23     9     32  
Not Hispanic or Latino     80     41     121  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
White     62     30     92  
Black or African American     36     17     53  
Asian     2     1     3  
Native Hawaiian or Other Pacific Islander     1     1     2  
Other     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     103     50     153  
HIV-1 RNA  
[units: log10 copies/mL]
Mean (Standard Deviation)
  4.70  (0.516)     4.65  (0.514)     4.68  (0.515)  
HIV-1 RNA Category  
[units: participants]
     
≤ 100,000 copies/mL     80     43     123  
> 100,000 to ≤ 400,000 copies/mL     17     5     22  
> 400,000 copies/mL     6     2     8  
CD4 Cell Count  
[units: cells/µL]
Mean (Standard Deviation)
  395  (169.3)     464  (261.6)     417  (205.7)  
CD4 Cell Count Category  
[units: participants]
     
< 50 cells/μL     1     1     2  
50 to ≤ 199 cells/µL     10     9     19  
200 to ≤ 349 cells/µL     37     8     45  
351 to ≤ 499 cells/µL     27     12     39  
≥ 500 cells/μL     28     20     48  



  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 HIV-1 RNA at Week 24   [ Time Frame: Baseline; Week 24 ]

4.  Secondary:   Change From Baseline in HIV-1 RNA at Week 48   [ Time Frame: Baseline; Week 48 ]

5.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 24   [ Time Frame: Baseline; Week 24 ]

6.  Secondary:   Change From Baseline in CD4+ Cell Count 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



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01565850     History of Changes
Other Study ID Numbers: GS-US-299-0102
Study First Received: March 27, 2012
Results First Received: March 11, 2016
Last Updated: March 11, 2016
Health Authority: United States: Food and Drug Administration