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

December 22, 2014 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse events reported during Atazanavir drug exposure
Time Frame: 36 months
Timeframe of the study
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12-months
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
24-months
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
36-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

PENTA Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 6, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI424-450

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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