Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment

Completed · Phase 3

Conditions studied: Acquired Immunodeficiency Syndrome, HIV Infections

In brief

This study is to characterize the effect of cobicistat-based regimens on parameters of renal function in participants with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.

Key facts

Study ID

NCT01363011

Run by

Gilead Sciences

People needed

106

Starts

2011-05-01

Expected to finish

2015-02-01

Last updated by the study team

2016-05-02

Who can join

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

You may qualify if…

• Cohort 1 (treatment-naive)
• Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
• Screening genotype report must show sensitivity to FTC and TDF
• No prior use of any approved or investigational antiretroviral drug for any length of time
• Cohort 2 (treatment-experienced, pharmacoenhancer switch)
• Subjects must be receiving ATV 300 mg/ritonavir (RTV) 100 mg plus 2 NRTIs OR DRV 800 mg/RTV 100 mg plus 2 NRTIs for at least 6 months prior to screening
• Plasma HIV-1 RNA concentrations at undetectable levels in the 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening
• Subjects experiencing intolerance to RTV (as determined by the investigator)
• Both groups
• The ability to understand and sign a written informed consent form
• Normal ECG
• Mild to moderate renal function
• Stable renal function
• Hepatic transaminases (AST and ALT) ≤ 5 x the upper limit of the normal range (ULN)
• Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (subjects with documented Gilbert's Syndrome or hyperbilirubinemia due to atazanavir therapy may have total bilirubin up to 5 x ULN)
• 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

You may not qualify if…

• 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)
• Implanted defibrillator or pacemaker
• Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance
• History of malignancy within the past 5 years or ongoing malignancy 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
• Receiving ongoing therapy with any of medications contraindicated for use with elvitegravir (EVG), COBI, FTC, TDF, ATV, DRV; or subjects with any known allergies to the excipients of E/C/F/TDF STR, COBI tablets, ATV capsules or DRV tablets or contraindicated for the 2 NRTIs as part of the PI/co regimen
• Participation in any other clinical trial without prior approval
• 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

• Health for Life Clinic — Little Rock, Arkansas, United States
• AHF Research Center — Beverly Hills, California, United States
• Kaiser Permanente — Los Angeles, California, United States
• Peter J. Ruane, M.D., Inc. — Los Angeles, California, United States
• Anthony Mills, MD, Inc. — Los Angeles, California, United States
• Orange Coast Medical Group — Newport Beach, California, United States
• East Bay AIDS Center — Oakland, California, United States
• University of California, Davis — Sacramento, California, United States
• Metropolis Medical — San Francisco, California, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University School of Medicine AIDS Program — New Haven, Connecticut, United States
• Whitman Walker Clinic — Washington D.C., District of Columbia, United States
• Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Therafirst Medical Center — Fort Lauderdale, Florida, United States
• Broward Health — Fort Lauderdale, Florida, United States
• Gary J. Richmond.M.D.,P.A. — Fort Lauderdale, Florida, United States
• Midway Immunology and Research Center — Ft. Pierce, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• IDOCF/ValueHealthMD, LLC — Orlando, Florida, United States
• Infectious Disease Specialists of Atlanta — Decatur, Georgia, United States
• Mercer University/ Mercer Medicine Clinical Research — Macon, Georgia, United States
• Northstar Medical Center — Chicago, Illinois, United States
• The Research Institute — Springfield, Massachusetts, United States
• Central West Clinical Research, Inc. — St Louis, Missouri, United States
• Spectrum Medical Group — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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