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Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected 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:
NCT01363011
First received: May 11, 2011
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: October 27, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Interventions: Drug: Stribild
Drug: COBI
Drug: ATV
Drug: DRV
Drug: NRTI

  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 a total of 40 study sites in Australia, Europe, and North America. The first participant was screened on 13 May 2011. The last participant observation for the Week 48 analysis occurred on 19 July 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cohort 1 Participants who had not received prior antiretroviral (ARV) treatment and who were virologically unsuppressed at baseline initiated treatment with Stribild (EVG 150 mg/cobicistat [COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) single-tablet regimen (STR) for up to 96 weeks.
Cohort 2 Participants who had received prior ARV treatment and who were virologically suppressed at baseline continued their treatment regimen, switching the regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, and continuing their existing protease inhibitor (PI; atazanavir [ATV] 300 mg or darunavir [DRV] 800 mg)/2 nucleoside reverse transcriptase inhibitors (NRTI) regimen for up to 96 weeks.

Participant Flow:   Overall Study
    Cohort 1     Cohort 2  
STARTED     33     73  
COMPLETED     0     2  
NOT COMPLETED     33     71  
Adverse Event                 2                 3  
Investigator's Discretion                 1                 1  
Withdrew Consent                 1                 8  
Lost to Follow-up                 0                 1  
Protocol Violation                 0                 1  
Subject Still on Study                 29                 57  



  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 randomized and received at least one dose of study medication

Reporting Groups
  Description
Cohort 1 Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR for up to 96 weeks.
Cohort 2 Participants who had received prior ARV treatment and who were virologically suppressed at baseline continued their treatment regimen, switching the regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, and continuing their existing PI (ATV 300 mg or DRV 800 mg)/2 NRTI regimen for up to 96 weeks.
Total Total of all reporting groups

Baseline Measures
    Cohort 1     Cohort 2     Total  
Number of Participants  
[units: participants]
  33     73     106  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 12.1     54  ± 9.5     53  ± 10.5  
Gender  
[units: participants]
     
Female     6     13     19  
Male     27     60     87  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     0     1     1  
Black or African Heritage     13     14     27  
White     14     56     70  
Other     5     2     7  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic/Latino     9     19     28  
Non-Hispanic/Latino     24     54     78  
Region of Enrollment  
[units: participants]
     
United States     19     33     52  
Mexico     0     9     9  
Canada     4     2     6  
Dominican Republic     5     1     6  
Austria     0     2     2  
Australia     1     5     6  
Germany     0     3     3  
United Kingdom     4     18     22  
HIV Disease Status  
[units: participants]
     
Asymptomatic     28     37     65  
Symptomatic HIV Infection     3     18     21  
AIDS     2     18     20  
Hepatitis B Virus (HBV) Surface Antigen Status  
[units: participants]
     
Positive     1     4     5  
Negative     32     69     101  
Hepatitis C Virus (HCV) Antibody Status  
[units: participants]
     
Positive     2     10     12  
Negative     30     63     93  
Indeterminate     1     0     1  
HIV-1 RNA Category  
[units: participants]
     
< 50 copies/mL     0     73     73  
≥ 50 to < 1,000 copies/mL     0     0     0  
≥ 1,000 to ≤ 100,000 copies/mL     24     0     24  
> 100,000 copies/mL     9     0     9  
CD4 Cell Count  
[units: participants]
     
≤ 50 cells/µL     1     0     1  
51 to ≤ 200 cells/µL     3     3     6  
201 to ≤ 350 cells/µL     13     5     18  
351 to ≤ 500 cells/µL     10     16     26  
> 500 cells/µL     6     49     55  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)   [ Time Frame: Baseline; Week 24 ]

2.  Primary:   Change From Baseline in eGFR-CG at Week 24 (Cohort 2)   [ Time Frame: Baseline; Week 24 ]

3.  Primary:   Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)   [ Time Frame: Baseline; Week 24 ]

4.  Primary:   Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2)   [ Time Frame: Baseline; Week 24 ]

5.  Primary:   Change From Baseline in eGFR Using the Chronic Kidney Disease, Epidemiology Collaboration (CKD-EPI) Formula Based on Cystatin C Equation at Week 24 (Cohort 1)   [ Time Frame: Baseline; Week 24 ]

6.  Primary:   Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2)   [ Time Frame: Baseline; Week 24 ]

7.  Primary:   Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 1)   [ Time Frame: Baseline; Week 24 ]

8.  Primary:   Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 2)   [ Time Frame: Baseline; Week 24 ]

9.  Primary:   Change From Baseline in Actual Glomerular Filtration Rate (aGFR) at Weeks 2, 4, and 24 (Cohort 1)   [ Time Frame: Baseline; Weeks 2, 4, and 24 ]

10.  Primary:   Change From Baseline in aGFR at Weeks 2, 4, and 24 (Cohort 2)   [ Time Frame: Baseline; Weeks 2, 4, and 24 ]

11.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 1)   [ Time Frame: Week 24 ]

12.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 2)   [ Time Frame: Week 24 ]

13.  Secondary:   Change From Baseline in eGFR-CG at Week 48 (Cohort 1)   [ Time Frame: Baseline; Week 48 ]

14.  Secondary:   Change From Baseline in eGFR-CG at Week 48 (Cohort 2)   [ Time Frame: Baseline; Week 48 ]

15.  Secondary:   Change From Baseline in eGFR-MDRD at Week 48 (Cohort 1)   [ Time Frame: Baseline; Week 48 ]

16.  Secondary:   Change From Baseline in eGFR-MDRD at Week 48 (Cohort 2)   [ Time Frame: Baseline; Week 48 ]

17.  Secondary:   Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Week 48 (Cohort 1)   [ Time Frame: Baseline; Week 48 ]

18.  Secondary:   Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Week 48 (Cohort 2)   [ Time Frame: Baseline; Week 48 ]

19.  Secondary:   Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 48 (Cohort 1)   [ Time Frame: Baseline; Week 48 ]

20.  Secondary:   Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 48 (Cohort 2)   [ Time Frame: Baseline; Week 48 ]

21.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (Cohort 1)   [ Time Frame: Week 48 ]

22.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (Cohort 2)   [ Time Frame: Week 48 ]

23.  Secondary:   Percentage of Participants Who Experienced Adverse Events (Cohort 1)   [ Time Frame: Up to 48 weeks plus 30 days ]

24.  Secondary:   Percentage of Participants Who Experienced Adverse Events (Cohort 2)   [ Time Frame: Up to 48 weeks plus 30 days ]

25.  Secondary:   Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 1)   [ Time Frame: Up to 48 weeks plus 30 days ]

26.  Secondary:   Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 2)   [ Time Frame: Up to 48 weeks plus 30 days ]

27.  Secondary:   Plasma Pharmacokinetics of COBI: AUCtau (Cohort 1)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]

28.  Secondary:   Plasma Pharmacokinetics of COBI: AUCtau (Cohort 2)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]

29.  Secondary:   Plasma Pharmacokinetics of COBI: Cmax (Cohort 1)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]

30.  Secondary:   Plasma Pharmacokinetics of COBI: Cmax (Cohort 2)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]

31.  Secondary:   Plasma Pharmacokinetics of COBI: Ctau (Cohort 1)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]

32.  Secondary:   Plasma Pharmacokinetics of COBI: Ctau (Cohort 2)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]

33.  Secondary:   Plasma Pharmacokinetics of COBI: Tmax (Cohort 1)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]

34.  Secondary:   Plasma Pharmacokinetics of COBI: Tmax (Cohort 2)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]

35.  Secondary:   Plasma Pharmacokinetics of COBI: t1/2 (Cohort 1)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]

36.  Secondary:   Plasma Pharmacokinetics of COBI: t1/2 (Cohort 2)   [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]


  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, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01363011     History of Changes
Other Study ID Numbers: GS-US-236-0118
Study First Received: May 11, 2011
Results First Received: October 27, 2014
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration