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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01389310

Enrollment

249

Registered

2011-07-08

Start date

2011-07-31

Completion date

2014-02-28

Last updated

2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Pattern of use of Atazanavir	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

Countries

Belgium, Germany, Italy, Romania, Spain, Switzerland, United Kingdom

Outcome results