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Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

This study has been completed.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01440569
First received: September 22, 2011
Last updated: October 26, 2016
Last verified: October 2016
History of Changes
Results First Received: October 23, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Interventions: Drug: COBI
Drug: DRV
Drug: NRTIs

  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 56 study sites in the United States. The first participant was screened on 22 September 2011. The last study visit occurred on 30 October 2015.

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

Reporting Groups
  Description
Treatment-Naive Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Treatment-Experienced Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.

Participant Flow for 2 periods

 Period 1:   Main Study
    Treatment-Naive   Treatment-Experienced
STARTED   296   18 
Enrolled and Treated   295   18 
COMPLETED   260   14 
NOT COMPLETED   36   4 
Enrolled but not treated                1                0 
Adverse Event                9                0 
Pregnancy                1                0 
Investigator's Discretion                1                1 
Withdrew Consent                7                1 
Lost to Follow-up                13                2 
Subject Non-Compliance                3                0 
Protocol Violation                1                0 

Period 2:   Open-Label Rollover Phase
    Treatment-Naive   Treatment-Experienced
STARTED   251 [1]   13 [2] 
COMPLETED   204   7 
NOT COMPLETED   47   6 
Adverse Event                3                0 
Pregnancy                1                0 
Lack of Efficacy                2                0 
Investigator’s Discretion                3                1 
Withdrew Consent                11                1 
Lost to Follow-up                26                3 
Subject Non-Compliance                1                1 
[1] 9 participants who completed the Main Study did not enroll into the Rollover Phase.
[2] 1 participant who completed the Main Study did not enroll into the Rollover 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.
Full Analysis Set: participants who were enrolled into the study and received at least one dose of study drug.

Reporting Groups
  Description
Treatment-Naive Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Treatment-Experienced Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Total Total of all reporting groups

Baseline Measures
   Treatment-Naive   Treatment-Experienced   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 295   18   313 
Age 
[Units: Years]
Mean (Standard Deviation) 		 36  (10.3)   45  (10.9)   36  (10.6) 
Gender 
[Units: Participants]
Count of Participants 		     
Female      29   9.8%      5  27.8%      34  10.9% 
Male      266  90.2%      13  72.2%      279  89.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
Hispanic or Latino      64  21.7%      4  22.2%      68  21.7% 
Not Hispanic or Latino      231  78.3%      14  77.8%      245  78.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
 		     
White   176   11   187 
Black or African Heritage   101   7   108 
American Indian or Alaska Native   4   0   4 
Asian   4   0   4 
Native Hawaiian or Pacific Islander   2   0   2 
Other   8   0   8 
CD4 Count (cells/mm^3) 
[Units: Cells/mm^3]
Mean (Standard Deviation) 		 378.2  (199.94)   197.8  (214.30)   367.8  (204.79) 
HIV-1 RNA (log10 copies/mL) 
[Units: Log10 copies/mL]
Mean (Standard Deviation) 		 4.8  (0.76)   4.8  (1.04)   4.8  (0.78) 
Background Antiretroviral Regimen [1] 
[Units: Participants]
 		     
FTC/TDF   291   10   301 
AZT+FTC/TDF   0   5   5 
ABC+TDF   2   1   3 
ABC+FTC/TDF   1   1   2 
ABC/3TC   1   0   1 
DDI+FTC   0   1   1 
[1] 3TC, lamivudine (Epivir®); ABC, abacavir; ABC/3TC, abacavir/lamivudine coformulation; AZT, azidothymidine or zidovudine; DDI, didanosine; FTC, emtricitabine (Emtriva®); FTC/TDF, emtricitabine/tenofovir disoproxil fumarate coformulation (Truvada®); TDF, tenofovir disoproxil fumarate (Viread®)


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24   [ Time Frame: Up to 24 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)   [ Time Frame: Week 24 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)   [ Time Frame: Week 48 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 24   [ Time Frame: Baseline; Week 24 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 48   [ Time Frame: Baseline; Week 48 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24   [ Time Frame: Up to 24 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48   [ Time Frame: Up to 48 weeks ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
  Show 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



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01440569     History of Changes
Other Study ID Numbers: GS-US-216-0130
2011-003501-22 ( EudraCT Number )
Study First Received: September 22, 2011
Results First Received: October 23, 2014
Last Updated: October 26, 2016