Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
- Conditions
- Acquired Immunodeficiency SyndromeHIV Infections
- Interventions
- Registration Number
- NCT01440569
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 314
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description COBI-boosted DRV COBI Participants will receive DRV+COBI+2 investigator-selected NRTIs for 48 weeks, and may continue their regimen in the open-label rollover phase. COBI-boosted DRV DRV Participants will receive DRV+COBI+2 investigator-selected NRTIs for 48 weeks, and may continue their regimen in the open-label rollover phase. COBI-boosted DRV NRTIs Participants will receive DRV+COBI+2 investigator-selected NRTIs for 48 weeks, and may continue their regimen in the open-label rollover phase.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24 Up to 24 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24 Up to 24 weeks Change From Baseline in CD4+ Cell Count at Week 48 Baseline; Week 48 Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48 Up to 48 weeks Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis) Week 24 Change From Baseline in CD4+ Cell Count at Week 24 Baseline; Week 24 Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis) Week 48
Trial Locations
- Locations (49)
Gary J. Richmond,M.D., P.A.
🇺🇸Fort Lauderdale, Florida, United States
Atlanta ID group
🇺🇸Atlanta, Georgia, United States
Mercer University
🇺🇸Macon, Georgia, United States
Howard Brown Health Center
🇺🇸Chicago, Illinois, United States
Community Research Initiative of New England
🇺🇸Boston, Massachusetts, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
North Shore University Hospital / Division of Infectious Diseases
🇺🇸Manhasset, New York, United States
University of PA
🇺🇸Philadelphia, Pennsylvania, United States
Trinity Health and Wellness Center/AIDS Arms, Inc.
🇺🇸Dallas, Texas, United States
Southwest Infectious Disease Clinical Research, Inc.
🇺🇸Dallas, Texas, United States
Therapeutic Concepts, PA
🇺🇸Houston, Texas, United States
Gordon Crofoot MD, PA
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
La Playa Medical Group and Clinical Research
🇺🇸San Diego, California, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
🇺🇸Annandale, Virginia, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
HIV Program Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Peter J Ruane MD Inc.
🇺🇸Los Angeles, California, United States
Long Beach Education and Research Consultants, PC
🇺🇸Long Beach, 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
Metropolis Medical
🇺🇸San Francisco, California, United States
Apex Research LLC
🇺🇸Denver, Colorado, United States
Dupont Circle Physician's Group
🇺🇸Washington, District of Columbia, United States
Whitman-Walker Health
🇺🇸Washington, District of Columbia, United States
Midway Immunology and Research Center
🇺🇸Fort 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
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
Hawaii Center for AIDS, University of Hawaii
🇺🇸Honolulu, Hawaii, United States
Northstar Medical Center
🇺🇸Chicago, Illinois, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
Central West Clinical Research Inc
🇺🇸St. Louis, Michigan, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Greiger Clinic
🇺🇸Mt. Vernon, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Carolinas Medical Center-Myer's Park Infectious Disease Clinic
🇺🇸Charlotte, North Carolina, United States
Wake Forest University Health Services
🇺🇸Winston-Salem, North Carolina, United States
Tarrant County Infectious Disease
🇺🇸Fort Worth, Texas, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico