Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01389310 |
Recruitment Status
:
Completed
First Posted
: July 8, 2011
Last Update Posted
: December 23, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

Group/Cohort |
---|
HIV-infected children <18 yrs old - exposed to Atazanavir |
- Number of Adverse events reported during Atazanavir drug exposure [ Time Frame: 36 months ]Timeframe of the study
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
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 |
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:
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 |