The objective of this study is to evaluate the safety and efficacy of a single tablet regimen containing fixed doses of elvitegravir/emtricitabine/tenofovir disoproxil fumarate/GS 9350 versus Atripla in HIV 1 infected, antiretroviral treatment-naive adult subjects.

This new QUAD tablet of elvitegravir/emtricitabine/tenofovir disoproxil fumarate/GS 9350 could offer an alternative fixed-dose regimen for patients who cannot tolerate Atripla or are women of childbearing potential (due to the potential teratogenecity of efavirenz, a component of Atripla).

Double-blinded, multicenter, randomized, active-controlled study to assess the safety and efficacy of a regimen containing elvitegravir/emtricitabine/tenofovir disoproxil fumarate/GS 9350 versus Atripla in HIV 1 infected, antiretroviral treatment-naive adult subjects.

Subjects will be randomized in a 2:1 ratio to one of the following two treatment arms:

Treatment Arm 1: Fixed-dose combination tablet of elvitegravir (EVG) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg/GS 9350 150 mg QD + Placebo for Atripla QHS (n = 50)

Treatment Arm 2: Atripla QHS + Placebo for fixed-dose combination tablet of elvitegravir (EVG) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg/GS 9350 150 mg QD (n = 25)

Randomization will be stratified by HIV 1 RNA level (less than or equal to 100,000 copies/mL or greater than 100,000 copies/mL) at screening.

After Week 48, subjects will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded, at which point all subjects will return for an Unblinding Visit and will be given the option to participate in an open label rollover extension and receive the EVG/FTC/TDF/GS 9350 fixed-dose combination tablet until it becomes commercially available, or until Gilead Sciences elects to terminate the study.

• HIV-1 Infection
• HIV Infections

• Drug: Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350
• Drug: Atripla

• Experimental: Fixed-dose combination tablet of elvitegravir (EVG) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg/GS 9350 150 mg QD + Placebo for Atripla QHS (n=50)
• Active Comparator: Atripla QHS + Placebo for fixed-dose combination tablet of elvitegravir (EVG) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg/GS 9350 150 mg QD (n=25)

Inclusion Criteria:

• Plasma HIV 1 RNA levels greater than or equal to 5,000 copies/mL
• No prior use of any approved or experimental anti-HIV drug
• Normal ECG
• Adequate renal function
• Hepatic transmaninases less than or equal to 2.5 x upper limit of normal
• Total bilirubin less than or equal to 1.5 mg/dL, or normal direct bilirubin
• Adequate hematologic function
• CD4+ cell count greater than 50 cells/uL
• Serum amylase less than or equal to 1.5 x ULN
• Normal TSH
• Negative serum pregnancy test (for females of childbearing potential only)
• Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drugs
• Age greater than or equal to 18 years
• Life expectancy greater than or equal to 1 year
• Ability to understand and sign a written informed consent form

Exclusion Criteria:

• New AIDS defining condition diagnosed within the 30 days prior to screening
• Documented drug resistance to NRTIs or NNRTIs or primary PI resistance mutation(s)
• Hepatitis B surface Antigen positive
• Hepatitis C Antibody positive
• Subjects experiencing cirrhosis
• Subjects experiencing ascites
• Subjects experiencing encephalopathy
• Females who are breastfeeding
• Positive serum pregnancy test (female of childbearing potential)
• Vaccinated within 90 days of study dosing
• History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30
• Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
• Prolonged QTcF interval at screening
• PR interval greater than or equal to 200 msec or less than or equal to 120 msec on ECG at screening
• QRS greater than or equal to 120 msec on ECG at screening
• Implanted defibrillator or pacemaker
• Subjects receiving ongoing therapy with any disallowed medications
• Current alcohol or substance use judged to potentially interfere with subject study compliance
• History of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
• Participation in any other clinical trial without prior approval
• Medications contraindicated for use with atazanavir, ritonavir, emtricitabine, or tenofovir disoproxil fumarate
• Any known allergies to the excipients of atazanavir capsules, ritonavir capsules, GS-9350 tablets or Truvada(R) (FTC/TDF) tablets
• Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements