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Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01968551
First received: September 26, 2013
Last updated: July 7, 2017
Last verified: July 2017
Results First Received: July 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HIV-1
HIV Infections
Acquired Immunodeficiency Syndrome
Interventions: Drug: E/C/F/TAF
Drug: DRV
Drug: Baseline DRV- containing ARV regimen

  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 Canada. The first participant was screened on 3 September 2013. The last study visit occurred on 09 July 2016.

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

Reporting Groups
  Description
Cohort 1: E/C/F/TAF+DRV

Open-Label (OL) Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily

Cohort 2: E/C/F/TAF+DRV

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Cohort 2: Stay on Baseline Regimen (SBR)

Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily


Participant Flow for 2 periods

Period 1:   Open Label Phase (48 Weeks)
    Cohort 1: E/C/F/TAF+DRV   Cohort 2: E/C/F/TAF+DRV   Cohort 2: Stay on Baseline Regimen (SBR)
STARTED   22   90   46 
COMPLETED   20   87   41 
NOT COMPLETED   2   3   5 
Randomized but Never Treated                1                1                0 
Investigator’s Discretion                0                1                0 
Withdrew Consent                1                1                3 
Lost to Follow-up                0                0                2 

Period 2:   Extension Phase
    Cohort 1: E/C/F/TAF+DRV   Cohort 2: E/C/F/TAF+DRV   Cohort 2: Stay on Baseline Regimen (SBR)
STARTED   20   87   34 [1] 
COMPLETED   19   86   30 
NOT COMPLETED   1   1   4 
Adverse Event                0                0                2 
Death                0                1                0 
Withdrew Consent                0                0                1 
Lost to Follow-up                1                0                1 
[1] 7 participant completed the Open-Label Phase, but did not enter in the Extension Phase



  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 included:

  • Cohort 1: participants who (1) were enrolled into Cohort 1 and (2) received at least 1 dose of study drug during the OL Phase or the Extension Phase
  • Cohort 2: participants who (1) were randomized into Cohort 2 and (2) received at least 1 dose of study drug during the OL Phase or the Extension Phase

Reporting Groups
  Description
Cohort 1: E/C/F/TAF+DRV

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Cohort 2: E/C/F/TAF+DRV

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Cohort 2: SBR

Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Total Total of all reporting groups

Baseline Measures
   Cohort 1: E/C/F/TAF+DRV   Cohort 2: E/C/F/TAF+DRV   Cohort 2: SBR   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   89   46   156 
Age 
[Units: Years]
Mean (Standard Deviation)
 53  (5.7)   49  (8.2)   47  (9.4)   49  (8.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      8  38.1%      16  18.0%      18  39.1%      42  26.9% 
Male      13  61.9%      73  82.0%      28  60.9%      114  73.1% 
Race/Ethnicity, Customized 
[Units: Participants]
       
American Indian or Alaska Native   0   1   0   1 
Asian   0   1   0   1 
Black   12   35   26   73 
Native Hawaiian or Pacific Islander   0   1   0   1 
White   9   51   17   77 
Not Permitted   0   0   0   0 
Other   0   0   3   3 
Race/Ethnicity, Customized 
[Units: Participants]
       
Hispanic or Latino   2   12   7   21 
Not Hispanic or Latino   19   77   39   135 
Not Permitted   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Canada   0   9   3   12 
United States   21   80   43   144 
HIV-1 RNA Category 
[Units: Participants]
       
< 50 copies/mL   19   87   46   152 
≥ 50 copies/mL   2   2   0   4 
CD4 Cell Count 
[Units: cells/µL]
Mean (Standard Deviation)
 700  (372.5)   562  (260.8)   571  (245.2)   583  (275.9) 
CD4 Cell Count Category 
[Units: Participants]
       
< 200 cells/µL   1   5   1   7 
≥ 200 to < 350 cells/µL   3   15   7   25 
≥ 350 cells/µL   17   69   38   124 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24   [ Time Frame: Week 24 ]

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

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

4.  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
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  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:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01968551     History of Changes
Other Study ID Numbers: GS-US-292-0119
Study First Received: September 26, 2013
Results First Received: July 20, 2016
Last Updated: July 7, 2017