Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01818596
First received: March 22, 2013
Last updated: January 21, 2016
Last verified: January 2016
Results First Received: December 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Intervention: Drug: E/C/F/TAF

  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, Asia, and Europe. The first participant was screened on 27 March 2013. The last Week 24 study visit occurred on 31 July 2014.

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

Reporting Groups
  Description
Cohort 1 (Treatment-experienced) Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants
Cohort 2 (Treatment-naive) E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants

Participant Flow:   Overall Study
    Cohort 1 (Treatment-experienced)     Cohort 2 (Treatment-naive)  
STARTED     246     6  
COMPLETED     0     0  
NOT COMPLETED     246     6  
Enrolled but Not Treated                 4                 0  
Adverse Event                 4                 0  
Withdrew Consent                 3                 0  
Protocol Violation                 1                 0  
Lost to Follow-up                 2                 0  
Still on Study                 232                 6  



  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 were enrolled and received at least 1 dose of study drug

Reporting Groups
  Description
Cohort 1 (Treatment-experienced) E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
Cohort 2 (Treatment-naive) E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Total Total of all reporting groups

Baseline Measures
    Cohort 1 (Treatment-experienced)     Cohort 2 (Treatment-naive)     Total  
Number of Participants  
[units: participants]
  242     6     248  
Age  
[units: years]
Mean (Standard Deviation)
  58  (9.9)     55  (7.1)     58  (9.8)  
Gender  
[units: participants]
     
Female     50     0     50  
Male     192     6     198  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     34     1     35  
American Indian or Alaska Native     1     0     1  
Black or African American     44     3     47  
Native Hawaiian or Pacific Islander     2     0     2  
White     152     2     154  
Other     7     0     7  
Not Permitted     2     0     2  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     31     1     32  
Not Hispanic or Latino     209     5     214  
Not Permitted     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     166     5     171  
United Kingdom     5     0     5  
Thailand     30     1     31  
Spain     13     0     13  
Netherlands     2     0     2  
Dominican Republic     6     0     6  
Mexico     2     0     2  
Australia     12     0     12  
France     6     0     6  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24   [ Time Frame: Baseline; Week 24 ]

2.  Primary:   Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24   [ Time Frame: Baseline; Week 24 ]

3.  Primary:   Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24   [ Time Frame: Baseline; Week 24 ]

4.  Secondary:   Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy   [ Time Frame: Baseline; Week 2, 4, or 8; Week 24 ]

5.  Secondary:   Percent Change From Baseline in C-type Collagen Sequence (CTX) at Week 24   [ Time Frame: Baseline; Week 24 ]

6.  Secondary:   Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Week 24   [ Time Frame: Baseline; Week 24 ]

7.  Secondary:   Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Week 24   [ Time Frame: Baseline; Week 24 ]

8.  Secondary:   Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Week 24   [ Time Frame: Baseline; Week 24 ]

9.  Secondary:   Percentage of Participants Experiencing Adverse Events or Graded Laboratory Abnormalities   [ Time Frame: Baseline to Week 24 Data Cut (average 42 weeks) ]

10.  Secondary:   Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24   [ Time Frame: Week 24 ]

11.  Secondary:   Pharmacokinetic (PK) Parameter: Cmax of TAF   [ Time Frame: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose ]

12.  Secondary:   PK Parameter: Tmax of TAF   [ Time Frame: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose ]

13.  Secondary:   PK Parameter: Clast of TAF   [ Time Frame: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose ]

14.  Secondary:   PK Parameter: Tlast of TAF   [ Time Frame: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose ]

15.  Secondary:   PK Parameter: λz of TAF   [ Time Frame: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose ]

16.  Secondary:   PK Parameter: AUCtau of TAF   [ Time Frame: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose ]

17.  Secondary:   PK Parameter: t1/2 of TAF   [ Time Frame: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose ]

18.  Secondary:   PK Parameter: AUCtau of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cell (PBMC) for Participants Enrolled in PK/PD Sub-study   [ Time Frame: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose ]


  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
Enrollment in Cohort 2 (treatment-naive) was low, which affects the interpretation of the data.


  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: NCT01818596     History of Changes
Other Study ID Numbers: GS-US-292-0112
2013-000516-25 ( EudraCT Number )
Study First Received: March 22, 2013
Results First Received: December 4, 2015
Last Updated: January 21, 2016
Health Authority: United States: Food and Drug Administration