Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
NCT ID: NCT01389310
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
249 participants
OBSERVATIONAL
2011-07-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HIV-infected children <18 yrs old - exposed to Atazanavir
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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PENTA Foundation
NETWORK
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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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
Other Identifiers
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AI424-450
Identifier Type: -
Identifier Source: org_study_id