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: February 26, 2014
Last verified: February 2014

July 6, 2011
February 26, 2014
July 2011
December 2013   (final data collection date for primary outcome measure)
Number of Adverse events reported during Atazanavir drug exposure [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Timeframe of the study
Same as current
Complete list of historical versions of study NCT01389310 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic

HIV Infection
Not Provided
HIV-infected children <18 yrs old - exposed to Atazanavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Germany,   Belgium,   Italy,   Spain,   Switzerland,   Romania
 
NCT01389310
AI424-450
No
Bristol-Myers Squibb
Bristol-Myers Squibb
PENTA Foundation
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP