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

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ClinicalTrials.gov Identifier: NCT01389310
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : December 23, 2014
Sponsor:
Collaborator:
PENTA Foundation
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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.

Condition or disease
HIV Infection

Study Design
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Study Type : Observational
Actual Enrollment : 249 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe
Study Start Date : July 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort
HIV-infected children <18 yrs old - exposed to Atazanavir


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse events reported during Atazanavir drug exposure [ Time Frame: 36 months ]
    Timeframe of the study


Secondary Outcome Measures :
  1. Pattern of use of Atazanavir [ Time Frame: 12-months ]
    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

  2. Pattern of use of Atazanavir [ Time Frame: 24-months ]
    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

  3. Pattern of use of Atazanavir [ Time Frame: 36-months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01389310     History of Changes
Other Study ID Numbers: AI424-450
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents