Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
NCT ID: NCT01440569
Last Updated: 2016-12-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
314 participants
INTERVENTIONAL
2011-09-30
2015-10-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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COBI-boosted 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
150 mg tablet administered orally with food once daily
DRV
800 mg (2 x 400 mg tablets) administered orally with food once daily
NRTIs
Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.
Interventions
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COBI
150 mg tablet administered orally with food once daily
DRV
800 mg (2 x 400 mg tablets) administered orally with food once daily
NRTIs
Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Marshall Fordyce, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Henry Ford Hospital
Detroit, Michigan, United States
Central West Clinical Research Inc
Saint Louis, Michigan, United States
HIV Program Hennepin County Medical Center
Minneapolis, Minnesota, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
North Shore University Hospital / Division of Infectious Diseases
Manhasset, New York, United States
Greiger Clinic
Mount 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
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Services
Winston-Salem, North Carolina, United States
University of PA
Philadelphia, Pennsylvania, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Miriam Hospital
Providence, Rhode Island, United States
Central Texas Clinical Research
Austin, Texas, United States
Trinity Health and Wellness Center/AIDS Arms, Inc.
Dallas, Texas, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States
Tarrant County Infectious Disease
Fort Worth, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Gordon Crofoot MD, PA
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Clinical Research Puerto Rico
San Juan, , Puerto Rico
Countries
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Other Identifiers
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2011-003501-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-216-0130
Identifier Type: -
Identifier Source: org_study_id