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

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV, HIV Infections

In brief

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.

Key facts

Study ID

NCT01108510

Run by

Gilead Sciences

People needed

698

Starts

2010-04-01

Expected to finish

2015-04-01

Last updated by the study team

2016-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Spectrum Medical Group — Phoenix, Arizona, United States
• Health for Life Clinic PLLC — Little Rock, Arkansas, United States
• Living Hope Clinical Foundation — Long Beach, California, United States
• Kaiser Permanente — Los Angeles, California, United States
• Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic — Los Angeles, California, United States
• Peter J Ruane, MD, Inc — Los Angeles, California, United States
• Oasis Clinic — Los Angeles, California, United States
• Anthony Mills MD Inc — Los Angeles, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• Kaiser Permanente Medical Group — Sacramento, California, United States
• La Playa Medical Group and Clinical Research — San Diego, California, United States
• Metropolis Medical — San Francisco, California, United States
• Kaiser Permanente Medical Center, Clinical Trials Unit — San Francisco, California, United States
• Apex Research, LLC — Denver, Colorado, United States
• Dupont Circle Physicians Group — Washington D.C., District of Columbia, United States
• Whitman-Walker Clinic — Washington D.C., District of Columbia, United States
• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Therafirst Medical Center — Fort Lauderdale, Florida, United States
• Broward Health/Comprehensive Care Center — Fort Lauderdale, Florida, United States
• Midway Immunology and Research Center — Ft. Pierce, Florida, United States
• The Kinder Medical Group — Miami, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Wohlfeiler, Piperato and Associates, LLC — Miami Beach, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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