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.
- Conditions
- HIV in paediatric populationMedDRA version: 14.1Level: LLTClassification code 10020172Term: HIV infection NOSSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-024537-23-PL
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 95
• Confirmed HIV 1 infection diagnosed by protocol criteria
• Screening HIV RNA = 1000 copies/mL
• = 3 months to < 11 years of age at time of first treatment
• 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: 95
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
• 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method