Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV Infection

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT01389310

AI424-450

Details and patient eligibility

About

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.

Enrollment: 249 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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

Trial design

249 participants in 1 patient group

HIV-infected children <18 yrs old - exposed to Atazanavir