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Completed

NCT Number: NCT01389310

Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital St Pierre, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Adverse events reported during Atazanavir drug exposure

    Time frame: 36 months

    Timeframe of the study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • PENTA Foundation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 8, 2011
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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