Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder boosted with Ritonavir (RTV) Liquid in HIV Infected, Antiretroviral, Naive and Experienced Pediatric Subjects From 3 Months to Less Than 11 Years.

A Prospective Single Arm, Open-Label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder boosted with Ritonavir (RTV) with an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral, Naive and Experienced Pediatric Subjects from 3 Months to Less Than 11 Years Pediatric Atazanavir International Clinical Evaluation: the PRINCE II study Revised Protocol Number 04, incorporates amendment 07 and Administrative letter 01 - PRINCE II

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024537-23-GB

Enrollment

Registered

2011-04-27

Start date

2011-06-22

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV in paediatric population MedDRA version: 14.1 Level: LLT Classification code 10020172 Term: HIV infection NOS System Organ Class: 100000004862

Interventions

Trade Name: Reyataz Product Name: Atazanavir Product Code: BMS-232632 Pharmaceutical Form: Capsule, hard INN or Proposed INN: ATAZANAVIR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Confirmed HIV 1 infection diagnosed by protocol criteria • Screening HIV RNA = 1000 copies/mL • = 3 months to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 • Cardiac rhythm abnormalities • Need for Tenofovir • Weight Grade 2 AST/ALT • Coinfection with either HBV or HCV • Any active CDC Category C clinical condition

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the safety of ATV powder formulation boosted with RTV based HAART regimens in pediatric subjects dosed through 48 weeks, as measured by the frequency of deaths, serious adverse events and discontinuation due to AEs. ; Secondary Objective: 1) To describe efficacy as measured by proportions of subjects with a virologic response as defined by HIV RNA levels < 50 copies/mL and < 400 copies/mL by Roche Amplicor® HIV-1 RNA Assay (version 1.5), or AbbottRealTime HIV-1 assay after the Roche Amplicor assay is discontinued, through Week 48 of ATV powder formulation. 2) To describe the pharmacokinetic profile of ATV powder formulation boosted with RTV in pediatric subjects weighing ?= 25 to < 35 kgand/or who are = 6 to < 11 years of age, and for subjects enrolling in the new ?= 5 <10 kg cohort (200mg ATV and 80 mg RTV) in terms of ATV Cmax, Cmin and AUC. ; Primary end point(s): • The number of subjects who died • The frequency of Serious Adverse Events (SAEs) • The frequency of Adverse Events (AEs) leading to discontinuation ;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

Main Objective: To describe the safety of ATV powder formulation boosted with RTV based HAART regimens in pediatric subjects dosed through 48 weeks, as measured by the frequency of deaths, serious adverse events and discontinuation due to AEs. ; Secondary Objective: 1) To describe efficacy as measured by proportions of subjects with a virologic response as defined by HIV RNA levels < 50 copies/mL and < 400 copies/mL by Roche Amplicor® HIV-1 RNA Assay (version 1.5), or AbbottRealTime HIV-1 assay after the Roche Amplicor assay is discontinued, through Week 48 of ATV powder formulation. 2) To describe the pharmacokinetic profile of ATV powder formulation boosted with RTV in pediatric subjects weighing ?= 25 to < 35 kgand/or who are = 6 to < 11 years of age, and for subjects enrolling in the new ?= 5 <10 kg cohort (200mg ATV and 80 mg RTV) in terms of ATV Cmax, Cmin and AUC. ; Primary end point(s): • The number of subjects who died • The frequency of Serious Adverse Events (SAEs) • The frequency of Adverse Events (AEs) leading to discontinuation ;Timepoint(s) of evaluation of this end point: 48 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1- Proportions of subjects with HIV RNA = 25 - = 6 - < 11 years and new 5 -<10kg cohort (200mg ATV + 80mg RTV) ; Timepoint(s) of evaluation of this end point: 1- 48 weeks 2- 2 weeks after reaching this weight/age band	—

Countries

Argentina, Brazil, Chile, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, United Kingdom, United States

Contacts

Public ContactEU Study Start Up Unit

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026