Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
- Conditions
- HIV Infection
- Registration Number
- NCT01389310
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to monitor adverse events in HIV-infected children \<18 years old who are exposed to Atazanavir in a real-world setting in Europe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
- HIV-infected children participating in individual prospective paediatric HIV cohorts
- Receive Atazanavir treatment during 01JAN2011 to 30DEC2013
- Age <18 years old on the date starting an Atazanavir-containing regimen
- Have a minimum of 3 months of follow-up
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Adverse events reported during Atazanavir drug exposure 36 months Timeframe of the study
- Secondary Outcome Measures
Name Time Method Pattern of use of Atazanavir 36-months Atazanavir dosage administered, treatment duration (date started, date stopped), reason for dosage adjustment, withdrawal and reason for withdrawal, Ritonavir dose, other antiretroviral drug use, and other concomitant medications
Trial Locations
- Locations (9)
Hospital St Pierre
🇧🇪Brussels, Belgium
German Competence Network
🇩🇪Frankfurt, Germany
Victor Babes Hospital
🇷🇴Bucharest, Romania
Spanish Perinatal Cohort
🇪🇸Barcelona, Spain
Madrid Paediatric HIV Cohort
🇪🇸Madrid, Spain
Swiss Mother and Child HIV Cohort
🇨ðŸ‡Basel, Switzerland
Collaborative HIV Paediatric Study
🇬🇧London, United Kingdom
European Collaborative Study
🇬🇧London, United Kingdom
Italian Register for HIV-infection in Children
🇮🇹Florence, Italy