Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Inclusion Criteria:

- Ability to understand and sign a written informed consent form

- Plasma HIV-1 RNA levels ≥ 5,000 copies/mL

- No prior use of any approved or experimental anti-HIV drug

- Normal ECG (or if abnormal, determined by the investigator to be not clinically
significant)

- Adequate renal function (estimated glomerular filtration rate ≥ 80 mL/min according
to the Cockcroft-Gault formula)

- Hepatic transaminases ≤ 2.5 × upper limit of normal

- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

- Adequate hematologic function (absolute neutrophil count ≥ 1000/mm^3; platelets ≥
50,000/mm^3; hemoglobin ≥ 8.5 g/dL)

- Cluster of differentiation 4 (CD4) cell count > 50 cells/µL

- Serum amylase ≤ 1.5 × ULN (subjects with serum amylase >1.5 × ULN remained eligible
if serum lipase is ≤ 1.5 × ULN)

- Normal thyroid-stimulating hormone

- Negative serum pregnancy test (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 30 days following the last dose of study drugs

- Age ≥ 18 years

- Life expectancy ≥ 1 year

Exclusion Criteria:

- New AIDS-defining condition diagnosed within the 30 days prior to screening

- Documented drug resistance to nucleoside or nucleotide reverse transcriptase
inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), or
primary PI resistance mutation(s)

- Hepatitis B surface antigen positive

- Hepatitis C antibody positive

- Participants experiencing cirrhosis

- Participants experiencing ascites

- Participants 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 have a family history of sudden
cardiac death or unexplained death in an otherwise healthy individual under the age
of 30 years

- Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac
conduction abnormalities

- Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula)
interval at screening (eg, a prolongation of the QTcF interval of greater than 450
msec for males and greater than 470 msec for females)

- 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, 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

- Participation in any other clinical trial without prior approval

- Medications contraindicated for use with ATV, RTV, FTC, or TDF

- Any known allergies to the excipients of ATV capsules, RTV capsules, COBI tablets or
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