Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

Inclusion Criteria

• •Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
• •Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
• •No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP) or post-exposure prophylaxis (PEP), up to 6 months prior to screening
• •Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF)
• •Normal electrocardiogram (ECG)
• •Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
• •Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
• •Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
• •Adequate hematologic function
• •Serum amylase ≤ 5 × ULN
• •Males and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
• •Females 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
• •Females 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 at screening within the post-menopausal range based on the Central Laboratory reference range