A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV 1 Infected, Antiretroviral Treatment-Naive Adults
This study is to evaluate the safety, efficacy, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet regimen (STR) versus E/C/F/tenofovir disoproxil fumarate (TDF; E/C/F/TDF) STR 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 : E/C/F/TDF
- drug : Placebo to match E/C/F/TDF
- drug : E/C/F/TAF
- drug : Placebo to match E/C/F/TAF
Phase: Phase 2
Ages Eligible For Study:
- Ability to understand and sign a written informed consent form - Plasma HIV 1 RNA levels ? 5,000 copies/mL - No prior use of any approved or experimental anti-HIV drug for any length of time - Screening genotype report must show sensitivity to TDF and emtricitabine (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 the normal range (ULN) - Total bilirubin ? 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - CD4+ cell count > 50 cells/ÁL - Serum amylase ? 5 x ULN - 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 utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing - 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 at screening - 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 - Age ? 18 years - Life expectancy ? 1 year