Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Key Inclusion Criteria:

- Confirmed HIV-1 infection diagnosed by protocol criteria

- Screening HIV RNA level ≥1000 copies/mL

- ≥3 months to <11 years of age at time of first treatment

- Antiretroviral-naive or -experienced

- At screening, all participants must have genotypic sensitivity to atazanavir and at
least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which must be approved
for pediatric use at the local country.

- Antiretroviral-experienced patients must also have documented phenotypic sensitivity
at screening to atazanavir (Fold Change in susceptibility <2.2) and to at least 2
NRTIs that are approved in their country

Key Exclusion Criteria:

- Experienced participants who received atazanavir or atazanavir/ritonavir at any time
prior to study enrollment or who have a history of 2 or more protease inhibitor
failures

- Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to
study medications

- Cardiac rhythm abnormalities

- Need for tenofovir

- Weight <5 or ≥35kg

- >Grade 2 abnormality in aspartate transaminase/alanine transaminase levels

- Coinfection with either hepatitis B or C virus

- Any active Centers for Disease Control and Prevention Category C clinical condition