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

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