Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF 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 oftime

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

• Normal ECG

• Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according tothe 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 recommendedcontraception methods or be non-heterosexually active, or practice sexual abstinencefrom screening throughout the duration of the study period and for 30 days followingthe last dose of study drug

• Women who utilize hormonal contraceptive as one of their birth control methods musthave 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 toreceive 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'sstudy compliance

• History of malignancy within the past 5 years or ongoing malignancy other thancutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasivecutaneous squamous carcinoma

• Active, serious infections requiring parenteral antibiotic or antifungal therapywithin 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 unsuitablefor the study or unable to comply with the dosing requirements

• Females receiving ongoing therapy with any disallowed medications, including drugs notto be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with anyknown allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavircapsules or ritonavir tablets Note: Other protocol defined Inclusion/Exclusion criteria may apply.