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

Bristol-Myers Squibb249 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

249

Conditions

HIV Infection

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (9)

Hospital St Pierre

Brussels, Belgium

German Competence Network

Frankfurt, Germany

Italian Register for HIV-infection in Children

Florence, Italy

Victor Babes Hospital

Bucharest, Romania

Outcomes

Primary Outcomes

Number of Adverse events reported during Atazanavir drug exposure

Timeframe of the study

Time frame: 36 months

Secondary Outcomes

Pattern of use of Atazanavir

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

Time frame: 12-months

Pattern of use of Atazanavir

Time frame: 24-months

Pattern of use of Atazanavir

Time frame: 36-months

Data from ClinicalTrials.gov

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