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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389310
• Other study ID #: AI424-450
• Status: Completed
• Phase: N/A
• First received: July 6, 2011
• Last updated: December 22, 2014
• Start date: July 2011
• Est. completion date: February 2014

Study information

• Verified date: December 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
Belgium	Hospital St Pierre	Brussels
Germany	German Competence Network	Frankfurt
Italy	Italian Register for HIV-infection in Children	Florence
Romania	Victor Babes Hospital	Bucharest
Spain	Spanish Perinatal Cohort	Barcelona
Spain	Madrid Paediatric HIV Cohort	Madrid
Switzerland	Swiss Mother and Child HIV Cohort	Basel
United Kingdom	Collaborative HIV Paediatric Study	London
United Kingdom	European Collaborative Study	London

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	PENTA Foundation

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Romania,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse events reported during Atazanavir drug exposure	Timeframe of the study	36 months	Yes
Secondary	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	12-months	No
Secondary	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	24-months	No
Secondary	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	36-months	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form