A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted with Ritonavir (RTV) Liquid with an Optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I study)

Phase 2

Active, not recruiting

• Conditions: HIV; C02.782.815.616.400; B20-B24

• Registration Number: RBR-3vmkt2
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

HIV 1 infection diagnosed by protocol criteria. >= 3 months to < 5 years and 6 months of age at time of first treatment, and weight > 5 to < 25kg with any screening baseline plasma viral load. Antiretroviral naive and experienced. Screening HIV RNA >= 1000 copies/mL. Must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use at the local country. Subjects must have documented genotypic and phenotypic sensitivity at screening to ATV (Fold Change in susceptibility < 2.2) and to at least 2 NRTIs that are approved in their country.

Exclusion Criteria

Experienced subjects who received ATV or ATV/RTV at any time prior to study enrollment or who have prior history of 2 or more PI failures. Antiretroviral-naïve or experienced HIV-1 infected patients with contraindication to study medications. 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 ECG: 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). Use of Tenofovir.

Study & Design

• Study Type: Intervention
• Study Design: Not specified