Safety and Efficacy of E/C/F/TDF (Stribild®) Versus RTV-Boosted ATV Plus FTC/TDF (Truvada®) in HIV-1 Infected, Antiretroviral Treatment-Naive Women

Key Inclusion Criteria:

- Female (at birth), age ≥ 18 years

- Ability to understand and sign a written informed consent form

- Plasma HIV-1 RNA levels ≥ 500 copies/mL

- No prior use of any approved or investigational antiretroviral drug for any length of
time

- Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir
disoproxil fumarate (TDF) and atazanavir (ATV) boosted with ritonavir (RTV)

- Normal ECG

- Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to
the Cockcroft Gault formula

- Hepatic transaminases ≤ 5 x upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL

- Adequate hematologic function

- Serum amylase ≤ 5 x ULN

- Women of childbearing potential must agree to utilize protocol recommended
contraception methods or be non-heterosexually active, or practice sexual abstinence
from screening throughout the duration of the study period and for 30 days following
the last dose of study drug

- Women 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.

Key Exclusion Criteria:

- A new AIDS defining condition diagnosed within the 30 days

- Females receiving drug treatment for Hepatitis C, or females who are anticipated to
receive treatment for Hepatitis C during the course of the study

- Females experiencing decompensated cirrhosis

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Have an implanted defibrillator or pacemaker

- Have an ECG pulse rate interval ≥ 220 msec

- Current alcohol or substance use which may potentially interfere with the female's
study compliance

- 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

- Active, serious infections requiring parenteral antibiotic or antifungal therapy
within 30 days prior to baseline

- Participation in any other clinical trial without prior approval

- Any other clinical condition or prior therapy that would make the female unsuitable
for the study or unable to comply with the dosing requirements

- Females receiving ongoing therapy with any disallowed medications, including drugs not
to be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with any
known allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavir
capsules or ritonavir tablets

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