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
This study is to evaluate the efficacy darunavir/cobicistat/emtricitabine/GS-7340 (D/C/F/TAF) single-tablet regimen (STR) versus darunavir (DRV)+cobicistat (COBI)+emtricitabine(FTC)/tenofuvir 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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : D/C/F/TAF
- drug : DRV
- drug : COBI
- drug : Placebo to match FTC/TDF
- drug : Placebo to match D/C/F/TAF
- drug : Placebo to match DRV
- drug : Placebo to match COBI
- drug : FTC/TDF
Phase: Phase 2
Ages Eligible For Study:
- 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/ÁL - Treatment Na´ve: 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