D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
NCT ID: NCT01565850
Last Updated: 2016-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2012-04-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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D/C/F/TAF
D/C/F/TAF FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo
D/C/F/TAF
DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily
DRV Placebo
DRV placebo tablet administered orally once daily
COBI Placebo
COBI placebo tablet administered orally once daily
FTC/TDF Placebo
FTC/TDF placebo tablet administered orally once daily
DRV+COBI+FTC/TDF
DRV tablet plus COBI tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo
DRV
DRV 800 mg (2 × 400 mg tablets) administered orally once daily
COBI
COBI 150 mg tablet administered orally once daily
FTC/TDF
FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily
D/C/F/TAF Placebo
D/C/F/TAF placebo tablet administered orally once daily
Interventions
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D/C/F/TAF
DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily
DRV
DRV 800 mg (2 × 400 mg tablets) administered orally once daily
COBI
COBI 150 mg tablet administered orally once daily
FTC/TDF
FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily
D/C/F/TAF Placebo
D/C/F/TAF placebo tablet administered orally once daily
DRV Placebo
DRV placebo tablet administered orally once daily
COBI Placebo
COBI placebo tablet administered orally once daily
FTC/TDF Placebo
FTC/TDF placebo tablet administered orally once daily
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 which does not interfere with the assessments and the completion of the trial
* Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
* CD4+ cell count \> 50 cells/µL
* Treatment-naive: No prior use of any approved or experimental anti-HIV drug for any length of time
* Screening genotype report must show sensitivity to DRV, TDF and FTC
* Normal ECG
* Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
* Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 mg/dL
* Serum amylase ≤ 5 x ULN
* Adequate hematologic function
* Normal thyroid-stimulating hormone (TSH)
* Females of childbearing potential must have a negative serum pregnancy test
* 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
* Female subjects who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and hormonal failure
* Female subjects who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level test
* Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 90 days following discontinuation of investigational medicinal product
Exclusion Criteria
* Hepatitis B surface antigen positive
* Hepatitis C antibody positive
* Proven acute hepatitis in the 30 days prior to study entry
* Have a history or experiencing decompensated cirrhosis
* Current alcohol or substance use that potentially interferes with study compliance
* Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
* Females who are breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Female subjects who utilize non-estrogen hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
* Have an implanted defibrillator or pacemaker
* 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 is prohibited while participating in this trial
* Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with darunavir and cobicistat
* Note: darunavir is a sulfonamide. Participants who previously experienced a sulfonamide allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and darunavir has been identified in patients participating in Phase 2 and Phase 3 trials.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Moupali Das, MD, MPH
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
AHF Research Center
Beverly Hills, California, United States
Kaiser Permanente
Los Angeles, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Anthony Mills MD, Inc
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
Alta Bates Summit Medical Center, East Bay AIDS Center
Oakland, 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
Kasier Permanente Medical Center
San Francisco, California, United States
TPMG--Clinical Trials Unit
San Francisco, California, United States
Apex Research
Denver, Colorado, United States
Denver Infectious Disease Consultants, PLLC
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
Capital Medical Associates, PC
Washington D.C., District of Columbia, United States
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
IDOCF/ValuhealthMD, LLC
Orlando, Florida, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University Mercer Medicine
Macon, Georgia, United States
Howard Brown Health Center
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Community Research Initiative (CRI)
Boston, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Central West Clinical Research Inc
St Louis, Missouri, United States
North Shore University Hospital / Division of Infectious Diseases
Manhasset, New York, United States
Weill Cornell Medical College
New York, New York, United States
ID Consultants, P.A.
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of South Carolina School of Medicine Division of Infectious Disease
Columbia, South Carolina, United States
Southwest Infectious Disease Clinical Research Inc
Dallas, Texas, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Gordon E. Crofoot, MD., PA
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
CARE-ID
Annandale, Virginia, United States
Peter Shalit, M.D.
Seattle, Washington, United States
Clinical Research Puerto Rico
San Juan, , Puerto Rico
Countries
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Other Identifiers
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GS-US-299-0102
Identifier Type: -
Identifier Source: org_study_id
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