Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
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| ClinicalTrials.gov Identifier: NCT01389310 |
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Recruitment Status
:
Completed
First Posted
: July 8, 2011
Last Update Posted
: December 23, 2014
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Sponsor:
Bristol-Myers Squibb
Collaborator:
PENTA Foundation
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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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.
| Condition or disease |
|---|
| HIV Infection |
| Study Type : | Observational |
| Actual Enrollment : | 249 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe |
| Study Start Date : | July 2011 |
| Actual Primary Completion Date : | February 2014 |
| Actual Study Completion Date : | February 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Group/Cohort |
|---|
| HIV-infected children <18 yrs old - exposed to Atazanavir |
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
Information from the National Library of Medicine
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01389310 History of Changes |
| Other Study ID Numbers: |
AI424-450 |
| First Posted: | July 8, 2011 Key Record Dates |
| Last Update Posted: | December 23, 2014 |
| Last Verified: | December 2014 |
Additional relevant MeSH terms:
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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 |