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

Not Recruiting

Trial ID: NCT01565850


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.

Official Title

A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults

Stanford Investigator(s)

Philip Grant
Philip Grant

Asst Prof-Univ Med Line, Medicine - Infectious Diseases


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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.


drug: D/C/F/TAF Placebo

drug: DRV Placebo

drug: COBI Placebo

drug: FTC/TDF Placebo

drug: D/C/F/TAF

drug: DRV

drug: COBI

drug: FTC/TDF

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debbie Slamowitz
(650) 723-2804