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 Greater Than or Equal to 3 Months to Less Than 8 Years. Revised Protocol 01, incorporating protocol amendment 02

Phase 1

• Conditions: HIV in paediatric population; MedDRA version: 14.0Level: LLTClassification code 10020172Term: HIV infection NOSSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-024537-23-ES
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-30
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

? Confirmed HIV 1 infection diagnosed by protocol criteria
? Screening HIV RNA ? 1000 copies/mL
? ? 3 months to < 7 years 6 months of age
? antiretroviral naive or experienced
? all subjects must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use at the local country.
? antiretroviral-experienced subjects must also have documented phenotypic sensitivity at screening to ATV (Fold Change in susceptibility < 2.2) and to at least 2 NRTIs that are approved in their country
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 < 5kg or >= 35kg
? > Grade 2 AST/ALT
? Coinfection with either HBV or HCV
? Any active CDC Category C clinical condition

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified