Safety Sudy of Atazanavir Capsules in the Treatment of HIV in Patients Ages 6 - 18 Years

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 naive or treatment-experienced with a detectable viral load
• Antiretroviral naive subjects must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use and dosed per local country label
• Antiretroviral experienced subjects must have documented genotypic and phenotypic sensitivity at screening to ATV (Fold Change in susceptibility < 2.2) and at least 2 NRTIs. NRTIs must be approved for pediatric use and dosed per local country label

Exclusion Criteria:

• Experienced subjects who received Atazanavir (ATV) or ATV/RTV at any time prior to study enrollment
• Antiretroviral-naive or experienced HIV-1 infected subjects with contraindication to study medications
• Documented cardiac conduction abnormality(ies) or significant cardiac dysfunction, or a history syncope
• Family history of QTc interval syndrome, Brugada syndrome or right ventricular dysplasia or with a corrected QTc interval at screening of > 440 ms

• One of the following cardiac rhythm abnormalities documented on the screening electrocardiogram (ECG):

  1. First degree atrioventricular (AV) block as defined by protocol
  2. 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 virus (HBV) or hepatitis C virus (HCV)