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Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
PENTA Foundation
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01389310
First received: July 6, 2011
Last updated: December 22, 2014
Last verified: December 2014
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Purpose
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.
| Condition |
|---|
| HIV Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Number of Adverse events reported during Atazanavir drug exposure [ Time Frame: 36 months ]Timeframe of the study
Secondary Outcome Measures:
- 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
- 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
- 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
| Enrollment: | 249 |
| Study Start Date: | July 2011 |
| Study Completion Date: | February 2014 |
| Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| HIV-infected children <18 yrs old - exposed to Atazanavir |
Eligibility| Ages Eligible for Study: | up to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Primary care clinic
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389310
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389310
Locations
| Belgium | |
| Hospital St Pierre | |
| Brussels, Belgium | |
| Germany | |
| German Competence Network | |
| Frankfurt, Germany | |
| Italy | |
| Italian Register for HIV-infection in Children | |
| Florence, Italy | |
| Romania | |
| Victor Babes Hospital | |
| Bucharest, Romania | |
| Spain | |
| Spanish Perinatal Cohort | |
| Barcelona, Spain | |
| Madrid Paediatric HIV Cohort | |
| Madrid, Spain | |
| Switzerland | |
| Swiss Mother and Child HIV Cohort | |
| Basel, Switzerland | |
| United Kingdom | |
| Collaborative HIV Paediatric Study | |
| London, United Kingdom | |
| European Collaborative Study | |
| London, United Kingdom | |
Sponsors and Collaborators
Bristol-Myers Squibb
PENTA Foundation
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01389310 History of Changes |
| Other Study ID Numbers: |
AI424-450 |
| Study First Received: | July 6, 2011 |
| Last Updated: | December 22, 2014 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 23, 2017