Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV-1 Infection

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) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.

Key facts

Study ID

NCT00892437

Run by

Gilead Sciences

People needed

85

Starts

2009-05-01

Expected to finish

2015-01-01

Last updated by the study team

2016-02-15

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
• Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
• No prior use of any approved or experimental anti-HIV drug
• Normal ECG (or if abnormal, determined by the investigator to be not clinically significant)
• Adequate renal function (estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula)
• Hepatic transaminases ≤ 2.5 × upper limit of normal
• Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
• Adequate hematologic function (absolute neutrophil count ≥ 1000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL)
• Cluster of differentiation 4 (CD4) cell count > 50 cells/µL
• Serum amylase ≤ 1.5 × ULN (subjects with serum amylase >1.5 × ULN remained eligible if serum lipase is ≤ 1.5 × ULN)
• Normal thyroid-stimulating hormone
• Negative serum pregnancy test (females of childbearing potential only)
• 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 drugs
• Age ≥ 18 years
• Life expectancy ≥ 1 year

You may not qualify if…

• New AIDS-defining condition diagnosed within the 30 days prior to screening
• Documented drug resistance to nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), or primary PI resistance mutation(s)
• Hepatitis B surface antigen positive
• Hepatitis C antibody positive
• Participants experiencing cirrhosis
• Participants experiencing ascites
• Participants experiencing encephalopathy
• Females who are breastfeeding
• Positive serum pregnancy test (female of childbearing potential)
• Vaccinated within 90 days of study dosing
• History or family history of Long QT Syndrome or have a family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30 years
• Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
• Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) interval at screening (eg, a prolongation of the QTcF interval of greater than 450 msec for males and greater than 470 msec for females)
• PR interval greater than or equal to 200 msec or less than or equal to 120 msec on ECG at screening
• QRS greater than or equal to 120 msec on ECG at screening
• Implanted defibrillator or pacemaker
• Subjects receiving ongoing therapy with any disallowed medications
• Current alcohol or substance use judged to potentially interfere with subject study compliance
• History of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
• Participation in any other clinical trial without prior approval
• Medications contraindicated for use with ATV, RTV, FTC, or TDF
• Any known allergies to the excipients of ATV capsules, RTV capsules, COBI tablets or FTC/TDF tablets
• Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements

Where it is running

• Southwest Center for HIV/AIDS — Phoenix, Arizona, United States
• Health for Life Clinic, PLLC — Little Rock, Arkansas, United States
• AIDS Healthcare Foundation-Research Center — Beverly Hills, California, United States
• The Living Hope Foundation — Long Beach, California, United States
• Peter J. Ruane, MD, Inc. — Los Angeles, California, United States
• Orange Coast Medical Group — Newport Beach, California, United States
• David J. Shamblaw, MD Inc. — San Diego, California, United States
• Metropolis Medical — San Francisco, California, United States
• Denver Infectious Disease Consultants, PLLC — 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
• Capital Medical Associates PC — Washington D.C., District of Columbia, United States
• Gary Richmond, MD, PA, Inc. — Fort Lauderdale, Florida, United States
• Wohlfeiler, Piperato and Associates, LLC — Miami Beach, Florida, United States
• ValuehealthMD, LLC — Orlando, Florida, United States
• St. Joseph's Comprehensive Research Institute — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Infectious Disease Specialists of Atlanta (IDSA) — Decatur, Georgia, United States
• Northstar Medical Center — Chicago, Illinois, United States
• Chase Brexton Health Services, Inc. — Baltimore, Maryland, United States
• Be Well Medical Center — Berkley, Michigan, United States
• Central West Healthcare — St Louis, Missouri, United States
• Southampton Healthcare, Inc. — St Louis, Missouri, United States
• Saint Michael's Medical Center — Newark, New Jersey, United States
• Southwest C.A.R.E. Center — Santa Fe, New Mexico, United States

Full record on ClinicalTrials.gov

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