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

Key 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

Key Exclusion Criteria:

- A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within
the 30 days prior to screening

- Hepatitis B surface antigen (HBsAg) positive

- Hepatitis C antibody positive

- Individuals experiencing decompensated cirrhosis

- Females who are breastfeeding

- Positive serum pregnancy test

- Have an implanted defibrillator or pacemaker

- Current alcohol or substance use judged by the Investigator to potentially interfere
with study compliance

- History of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous
squamous carcinoma

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline

- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the individual unsuitable for the study or unable to comply
with dosing requirements

- Participation in any other clinical trial (including observational trials) without
prior approval

- Individuals receiving ongoing therapy with drugs not to be used with elvitegravir,
cobicistat, emtricitabine, tenofovir DF, and TAF or individuals with any known
allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets

Note: Other protocol defined Inclusion/Exclusion criteria may apply.