Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
This study is currently recruiting participants.
Verified May 2013 by Bristol-Myers Squibb
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: May 21, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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 ] [ Designated as safety issue: Yes ]Timeframe of the study
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389310
Contacts
| Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Locations
| Belgium | |
| Hospital St Pierre | Recruiting |
| Brussels, Belgium | |
| Contact: , Site 001 | |
| Germany | |
| German Competence Network | Recruiting |
| Frankfurt, Germany | |
| Contact: , Site 009 | |
| Italy | |
| Italian Register for HIV-infection in Children | Recruiting |
| Florence, Italy | |
| Contact: , Site 002 | |
| Romania | |
| Victor Babes Hospital | Recruiting |
| Bucharest, Romania | |
| Contact: , Site 007 | |
| Spain | |
| Spanish Perinatal Cohort | Recruiting |
| Barcelona, Spain | |
| Contact: , Site 004 | |
| Madrid Paediatric HIV Cohort | Recruiting |
| Madrid, Spain | |
| Contact: , Site 003 | |
| Switzerland | |
| Swiss Mother and Child HIV Cohort | Recruiting |
| Basel, Switzerland | |
| Contact: , Site 005 | |
| United Kingdom | |
| Collaborative HIV Paediatric Study | Recruiting |
| London, United Kingdom | |
| Contact: , Site 006 | |
| European Collaborative Study | Recruiting |
| London, United Kingdom | |
| Contact: , Site 008 | |
Sponsors and Collaborators
Bristol-Myers Squibb
PENTA Foundation
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| 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: | May 21, 2013 |
| Health Authority: | European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Atazanavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013