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

• Status: Completed
• Trial end date: 2018-01-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Ritonavir

Criteria

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