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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection

Phase: N/A

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

Official title: Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of Adverse events reported during Atazanavir drug exposure

Secondary outcome:

Pattern of use of Atazanavir

Pattern of use of Atazanavir

Pattern of use of Atazanavir

Eligibility

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

Hospital St Pierre, Brussels, Belgium

German Competence Network, Frankfurt, Germany

Italian Register for HIV-infection in Children, Florence, Italy

Victor Babes Hospital, Bucharest, Romania

Spanish Perinatal Cohort, Barcelona, Spain

Madrid Paediatric HIV Cohort, Madrid, Spain

Swiss Mother and Child HIV Cohort, Basel, Switzerland

Collaborative HIV Paediatric Study, London, United Kingdom

European Collaborative Study, London, United Kingdom

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: July 2011
Last updated: December 22, 2014

Page last updated: August 23, 2015

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