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Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01967940
First Posted: October 23, 2013
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
Results First Submitted: May 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Acquired Immunodeficiency Syndrome
Interventions: Drug: TAF
Drug: Placebo
Drug: E/C/F/TAF
Drug: Current failing ARV regimen
Drug: ATV

  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, Uganda, Thailand, Russian Federation, and Dominican Republic. The first participant was screened on 25 October 2013. The last Day 10 study visit occurred on 09 May 2016.

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

Reporting Groups
  Description
Part 1 Sentinel Cohort TAF, Then Part 2 E/C/F/TAF+ATV

Part 1: Tenofovir alafenamide (TAF) 25 mg tablet once daily + their current failing regimen for 10 days

Part 2: Following a 14-day washout period, participants who had a > 0.5 log10 decline in HIV-1 RNA received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) single-tablet regimen (STR) plus atazanavir (ATV) 300 mg once daily for 48 weeks.

Part 1 Randomized Cohort TAF, Then Part 2 E/C/F/TAF+ATV

Part 1: TAF 25 mg tablet once daily + their current failing regimen for 10 days

Part 2: Following a 14-day washout period, participants who had a > 0.5 log10 decline in HIV-1 RNA received E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks.

Part 1 Randomized Cohort Placebo, Then Part 2 E/C/F/TAF+ATV

Part 1: Placebo once daily + their current failing regimen for 10 days

Part 2: Following a 14-day washout period, participants received E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks.


Participant Flow for 2 periods

Period 1:   Part 1
    Part 1 Sentinel Cohort TAF, Then Part 2 E/C/F/TAF+ATV   Part 1 Randomized Cohort TAF, Then Part 2 E/C/F/TAF+ATV   Part 1 Randomized Cohort Placebo, Then Part 2 E/C/F/TAF+ATV
STARTED   12   28   15 
COMPLETED   12   28   15 
NOT COMPLETED   0   0   0 

Period 2:   Part 2
    Part 1 Sentinel Cohort TAF, Then Part 2 E/C/F/TAF+ATV   Part 1 Randomized Cohort TAF, Then Part 2 E/C/F/TAF+ATV   Part 1 Randomized Cohort Placebo, Then Part 2 E/C/F/TAF+ATV
STARTED   8 [1]   16 [2]   14 [3] 
COMPLETED   0   0   0 
NOT COMPLETED   8   16   14 
Still on Study                8                16                14 
[1] 4 participants completed Part 1, but did not enter Part 2 of the study
[2] 12 participants completed Part 1, but did not enter Part 2 of the study
[3] 1 participant completed Part 1, but did not enter Part 2 of the study



  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.
Full Analysis Set: participants who enrolled into Part 1 of the study and received at least one dose of study drug in Part 1.

Reporting Groups
  Description
Part 1 Sentinel Cohort TAF TAF 25 mg tablet once daily + their current failing regimen for 10 days
Part 1 Randomized Cohort TAF TAF 25 mg tablet once daily + their current failing regimen for 10 days
Part 1 Randomized Cohort Placebo Placebo once daily + their current failing regimen for 10 days
Total Total of all reporting groups

Baseline Measures
   Part 1 Sentinel Cohort TAF   Part 1 Randomized Cohort TAF   Part 1 Randomized Cohort Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   28   15   55 
Age 
[Units: Years]
Mean (Standard Deviation)
 38  (7.3)   40  (9.1)   43  (8.2)   40  (8.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      3  25.0%      16  57.1%      4  26.7%      23  41.8% 
Male      9  75.0%      12  42.9%      11  73.3%      32  58.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      5  41.7%      0   0.0%      1   6.7%      6  10.9% 
Not Hispanic or Latino      7  58.3%      28 100.0%      14  93.3%      49  89.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Asian   0   5   5   10 
Black   3   22   9   34 
White   4   1   0   5 
Other   5   0   1   6 
Region of Enrollment 
[Units: Participants]
       
Russian Federation   2   1   0   3 
United States   5   3   0   8 
Dominican Republic   5   0   1   6 
Uganda   0   19   9   28 
Thailand   0   5   5   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10   [ Time Frame: Day 10 ]

2.  Secondary:   Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10   [ Time Frame: Baseline; Day 10 ]

3.  Secondary:   Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Incidence of Laboratory Parameters and Adverse Events at Weeks 24 and 48   [ Time Frame: Up to 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Weeks 24 and 48   [ Time Frame: Weeks 24 and 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Weeks 24 and 48   [ Time Frame: Weeks 24 and 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Weeks 24 and 48   [ Time Frame: Weeks 24 and 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Part 2: Change From Baseline in CD4+ Cell Count (Cells/μL) and Percentage at Weeks 24 and 48   [ Time Frame: Weeks 24 and 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Part 2: Pharmacokinetic (PK) Parameter: AUClast of TAF   [ Time Frame: Week 4 to Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Part 2: PK Parameter: Clast of TAF   [ Time Frame: Week 4 to Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Part 2: PK Parameter: Cmax of TAF, Tenofovir (TFV), ATV, and Elvitegravir (EVG)   [ Time Frame: Week 4 to Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Part 2: PK Parameter: AUCtau of TFV, ATV, and EVG   [ Time Frame: Week 4 to Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Part 2: PK Parameter: Ctau of TFV, ATV, and EVG   [ Time Frame: Week 4 to Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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: NCT01967940     History of Changes
Other Study ID Numbers: GS-US-292-0117
2013-002830-19 ( EudraCT Number )
First Submitted: October 18, 2013
First Posted: October 23, 2013
Results First Submitted: May 9, 2017
Results First Posted: June 12, 2017
Last Update Posted: September 13, 2017