Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01106586
First received: April 14, 2010
Last updated: October 23, 2014
Last verified: October 2014
Results First Received: September 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Interventions: Drug: Stribild
Drug: ATV/r + FTC/TDF

  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 146 sites in 16 countries. The first participant was screened on 06 April 2010. The last participant observation for the Week 144 analysis was on 09 August 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1017 subjects were screened and 715 were randomized. 708 randomized participants received at least 1 dose of study medication and comprise the Safety Analysis Set and the Intent-to-Treat (ITT) Analysis Set.

Reporting Groups
  Description
Stribild Stribild (elvitegravir [EVG] 150 mg/cobicistat [COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily
ATV/r + FTC/TDF ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily

Participant Flow:   Overall Study
    Stribild     ATV/r + FTC/TDF  
STARTED     353     355  
COMPLETED     0     0  
NOT COMPLETED     353     355  
Adverse Event                 8                 14  
Death                 1                 3  
Pregnancy                 1                 1  
Lack of Efficacy                 1                 0  
Investigator's Discretion                 3                 5  
Withdrew Consent                 12                 18  
Lost to Follow-up                 20                 16  
Subject Noncompliance                 12                 9  
Protocol Violation                 1                 0  
Subject Still on Study Treatment                 255                 259  
Subject Joined Other Study                 39                 30  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96   [ Time Frame: Week 96 ]

3.  Secondary:   The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144   [ Time Frame: Week 144 ]

4.  Secondary:   The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: Week 48 ]

5.  Secondary:   The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, and 144   [ Time Frame: Baseline; Weeks 48, 96, and 144 ]

6.  Secondary:   The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48   [ Time Frame: 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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