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

This study has been completed.
Sponsor:
Collaborator:
PENTA Foundation
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01389310
First received: July 6, 2011
Last updated: December 22, 2014
Last verified: December 2014
History of Changes
  Purpose

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.


Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Atazanavir
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Number of Adverse events reported during Atazanavir drug exposure [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    Timeframe of the study


Secondary Outcome Measures:
  • Pattern of use of Atazanavir [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    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

  • Pattern of use of Atazanavir [ Time Frame: 24-months ] [ Designated as safety issue: No ]
    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

  • Pattern of use of Atazanavir [ Time Frame: 36-months ] [ Designated as safety issue: No ]
    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
Enrollment: 249
Study Start Date: July 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV-infected children <18 yrs old - exposed to Atazanavir

  Eligibility
Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389310

Locations
Belgium
Hospital St Pierre
Brussels, Belgium
Germany
German Competence Network
Frankfurt, Germany
Italy
Italian Register for HIV-infection in Children
Florence, Italy
Romania
Victor Babes Hospital
Bucharest, Romania
Spain
Spanish Perinatal Cohort
Barcelona, Spain
Madrid Paediatric HIV Cohort
Madrid, Spain
Switzerland
Swiss Mother and Child HIV Cohort
Basel, Switzerland
United Kingdom
Collaborative HIV Paediatric Study
London, United Kingdom
European Collaborative Study
London, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
PENTA Foundation
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01389310     History of Changes
Other Study ID Numbers: AI424-450
Study First Received: July 6, 2011
Last Updated: December 22, 2014
Health Authority: European Union: European Medicines Agency

ClinicalTrials.gov processed this record on March 03, 2015