Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients (PRINCE2)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: HIV

Treatments: Drug: Atazanavir Sulphate; Drug: Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01335698

AI424-451

2010-024537-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 3 months to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Stage 1: Atazanavir + Ritonavir

Experimental group

Description:

Participants received atazanavir powder orally (dosed by weight: 5 to \<10 kg=150 mg, 5 to \<10 kg=200 mg, 10 to \<15 kg=200 mg, 15 to \<25 kg=250 mg, 25 to \<35 kg=300 mg) once daily for 24 to 48 weeks or a weight ≥35 kg. Participants also received ritonavir once daily for 24 to 48 weeks or weight ≥35 kg in the form of 80-mg/mL solution, orally (dosed by weight 5 to \<25 kg=80 mg, 25 to \<35 kg=100 mg); 100-mg capsule, orally (dosed by weight 25 to \<35 kg=100 mg); or 100-mg tablet, orally (dosed by weight 25 to \<35 kg=100 mg)

Treatment:

Drug: Ritonavir

Drug: Atazanavir Sulphate