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Clinical Trials/NCT01389310
NCT01389310
Completed
Not Applicable

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

Bristol-Myers Squibb9 sites in 7 countries249 target enrollmentJuly 2011
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ConditionsHIV Infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infection
Sponsor
Bristol-Myers Squibb
Enrollment
249
Locations
9
Primary Endpoint
Number of Adverse events reported during Atazanavir drug exposure
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
February 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of Adverse events reported during Atazanavir drug exposure

Time Frame: 36 months

Timeframe of the study

Secondary Outcomes

  • Pattern of use of Atazanavir(36-months)

Study Sites (9)

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