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Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT01108510
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : October 28, 2014
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:

The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.


Condition or disease Intervention/treatment Phase
HIV HIV Infections Drug: COBI Drug: RTV Drug: ATV Drug: FTC/TDF Drug: COBI placebo Drug: RTV placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 698 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Study Start Date : April 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: ATV+COBI+FTC/TDF
COBI + RTV placebo + ATV + FTC/TDF once daily
 Drug: COBI
Cobicistat (COBI) 150 mg tablet administered orally once daily
Other Names:
  • Tybost®
  • GS-9350

Drug: ATV
Atazanavir (ATV) 300 mg capsule administered orally once daily
Other Name: Reyataz®

Drug: FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
Other Name: Truvada®

Drug: RTV placebo
Placebo to match RTV administered orally once daily
Active Comparator: ATV+RTV+FTC/TDF
RTV + COBI placebo + ATV + FTC/TDF once daily
 Drug: RTV
Ritonavir (RTV) 100 mg tablet administered orally once daily
Other Name: Norvir®

Drug: ATV
Atazanavir (ATV) 300 mg capsule administered orally once daily
Other Name: Reyataz®

Drug: FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
Other Name: Truvada®

Drug: COBI placebo
Placebo to match COBI administered orally once daily


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.


Secondary Outcome Measures :
  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 [ Time Frame: Week 96 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.

  2. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 [ Time Frame: Week 144 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.

  3. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192 [ Time Frame: Week 192 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.

  4. Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline to Week 48 ]
  5. Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline to Week 96 ]
  6. Change From Baseline in CD4 Cell Count at Week 144 [ Time Frame: Baseline to Week 144 ]
  7. Change From Baseline in CD4 Cell Count at Week 192 [ Time Frame: Baseline to Week 192 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time
  • Screening genotype report must show sensitivity to FTC, TDF and ATV
  • Normal ECG
  • Adequate renal function (eGFR calculated using the Cockcroft-Gault equation ≥ 70 mL/min)
  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN
  • Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
  • Subjects experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Have an implanted defibrillator or pacemaker
  • Have an ECG PR interval ≥ 220 msec
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
  • A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline.
  • Medications contraindicated for use with COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets.
  • Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108510


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Huyen Cao, MD Gilead Sciences
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01108510    
Other Study ID Numbers: GS-US-216-0114
2009-016759-22 ( EudraCT Number )
First Posted: April 22, 2010    Key Record Dates
Results First Posted: October 28, 2014
Last Update Posted: May 23, 2016
Last Verified: April 2016
Keywords provided by Gilead Sciences:
Treatment Naive
HIV 1 Infected
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Atazanavir Sulfate
 Cobicistat
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors