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: September 24, 2014
Last verified: September 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 + Truvada

  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 48 analysis was on 13 September 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1017 subjects were screened; 715 were randomized (357 to the Stribild group and 358 to the ATV/r + Truvada group) of which 61.4% (439) had screening HIV-1 ribonucleic acid (RNA) ≤ 100,000 copies/mL. A total of 708 randomized participants received at least 1 dose of study medication and comprised the safety and intent-to treat (ITT) analysis sets.

Reporting Groups
  Description
Stribild Double-blind Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) + placebos to match ATV/r + Truvada once daily (QD)
ATV/r + Truvada Double-blind atazanavir 300 mg/ritonavir 100 mg (ATV/r) + emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (Truvada) + placebo to match Stribild QD

Participant Flow:   Overall Study
    Stribild     ATV/r + Truvada  
STARTED     353     355  
COMPLETED     0     0  
NOT COMPLETED     353     355  
Adverse Event                 13                 18  
Pregnancy                 1                 0  
Lack of Efficacy                 4                 1  
Physician Decision                 1                 3  
Withdrawal by Subject                 1                 6  
Lost to Follow-up                 7                 7  
Participant Noncompliance                 5                 5  
Protocol Violation                 1                 0  
Subjects Still on Study Treatment                 320                 315  



  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   [ Time Frame: Week 48 ]

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

3.  Secondary:   The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline to Week 48 ]

4.  Secondary:   The Percentage of Participants With HIV-1 RNA < 50 Copies/mL   [ 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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