Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

Completed · Phase 3

Conditions studied: Acquired Immunodeficiency Syndrome, HIV Infections

In brief

This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.

Key facts

Study ID

NCT01440569

Run by

Gilead Sciences

People needed

314

Starts

2011-09-01

Expected to finish

2015-10-01

Last updated by the study team

2016-12-14

Who can join

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

You may qualify if…

• Adult ≥ 18 years males or non-pregnant females
• Ability to understand and sign a written informed consent form
• General medical condition that does not interfere with the assessments and the completion of the trial
• Treatment Naive: No prior use of any approved or investigational antiretroviral drug for any length of time OR
• Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening
• Plasma HIV-1 RNA levels ≥ 1000 copies/mL at Screening
• Screening genotype report shows full sensitivity to two nucleoside analogue reverse transcriptase inhibitors (NRTIs) and no darunavir resistance-associated mutations
• Normal electrocardiogram (ECG)
• Hepatic transaminases ≤ 2.5 × upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 mg/dL
• Adequate hematologic function
• Serum amylase ≤ 2 × ULN and serum lipase ≤ 3 × ULN
• Adequate renal function: Estimated glomerular filtration rate ≥ 80 mL/min
• Females of childbearing potential must agree to utilize protocol-recommended methods of contraception, or be nonheterosexually active, practice sexual abstinence or have a vasectomized partner from Screening throughout the duration of the study period and for 30 days following the last dose of study drug.
• Male subjects must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse from the Screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or be nonheterosexually active, practice sexual abstinence, or be vasectomized.

You may not qualify if…

• Previous or current use of darunavir
• A new AIDS-defining condition diagnosed within the 30 days prior to Screening
• Females who are breastfeeding
• Positive serum pregnancy test (if female of childbearing potential)
• Proven or suspected acute hepatitis in the 30 days prior to study entry
• Subjects receiving drug treatment for hepatitis C virus (HCV), or subjects who are anticipated to receive treatment for HCV during the course of the study
• Have a history of ongoing active liver disease or experiencing decompensated cirrhosis irrespective of liver enzyme levels
• Have an implanted defibrillator or pacemaker
• Current alcohol or substance use that may interfere with subject study compliance
• A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma
• Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
• Participation in any other clinical trial
• Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements.
• Subjects receiving ongoing therapy with any of the medications, including drugs not to be used with cobicistat, darunavir, or investigator selected NRTIs; or subjects with any known allergies to cobicistat tablets, darunavir tablets or contraindications for the 2 NRTIs as part of the regimen.

Where it is running

• Spectrum Medical Group — Phoenix, Arizona, United States
• Long Beach Education and Research Consultants, PC — Long Beach, California, United States
• Peter J Ruane MD Inc. — Los Angeles, California, United States
• Anthony Mills MD Inc — Los Angeles, California, United States
• Stanford University — Palo Alto, 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
• Apex Research LLC — Denver, Colorado, United States
• Dupont Circle Physician's Group — Washington D.C., District of Columbia, United States
• Whitman-Walker Health — Washington D.C., District of Columbia, United States
• Gary J. Richmond,M.D., P.A. — Fort Lauderdale, Florida, United States
• Midway Immunology and Research Center — Ft. Pierce, Florida, United States
• Wohlfeiler, Piperato and Associates, LLC — Miami Beach, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• St. Joseph's Comprehensive Research Institute — Tampa, Florida, United States
• Atlanta ID group — Atlanta, Georgia, United States
• Infectious Disease Specialists of Atlanta — Decatur, Georgia, United States
• Mercer University — Macon, Georgia, United States
• Hawaii Center for AIDS, University of Hawaii — Honolulu, Hawaii, United States
• Howard Brown Health Center — Chicago, Illinois, United States
• Northstar Medical Center — Chicago, Illinois, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• Community Research Initiative of New England — Boston, Massachusetts, United States
• Be Well Medical Center — Berkley, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.