A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety of Atazanavir (ATV) Capsule Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less Than 18 Years

Study start date: November 30, 2012

Inclusion Criteria: Confirmed HIV-1 infection diagnosed by protocol criteria Male or female children, ≥ 6 years to <17 years 6 months of age at the time of first treatment Antiretroviral-naïve or treatment-experienced participants with a detectable viral load Antiretroviral-naïve participants must have genotypic sensitivity at screening to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which have been approved for pediatric use and dosed per local country label Antiretroviral-experienced participants must have documented genotypic and phenotypic sensitivity at screening to atazanavir (fold change in susceptibility <2.2) and at least 2 NRTIs, which have been approved for pediatric use and dosed per local country label. Exclusion Criteria: Experienced participants who received atazanavir with or without ritonavir at any time prior to study enrollment Antiretroviral-naive or -experienced HIV-1 infected patients with contraindication to study medications Documented cardiac conduction abnormality, significant cardiac dysfunction, or a history syncope Family history of QTc interval syndrome, Brugada syndrome, right ventricular dysplasia, or a corrected QTc interval of >440 ms at screening One of the following cardiac rhythm abnormalities documented on the screening electrocardiogram: First degree atrioventricular (AV) block, as defined by protocol Type I second degree AV block while awake, type II second degree AV block at any time, complete AV block at any time, or age-adjusted heart rate <2nd percentile Coinfection with either hepatitis B or C virus