D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

Completed · Phase 2 · Has a placebo group

Conditions studied: Acquired Immunodeficiency Syndrome, HIV Infections

In brief

This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.

Key facts

Study ID

NCT01565850

Run by

Gilead Sciences

People needed

153

Starts

2012-04-01

Expected to finish

2014-02-01

Last updated by the study team

2016-04-11

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 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

You may not qualify if…

• A new AIDS defining condition diagnosed within the 30 days prior to screening
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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