Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| PENTA Foundation | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-infected children <18 yrs old - exposed to Atazanavir |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse events reported during Atazanavir drug exposure | Timeframe of the study | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of use of Atazanavir | 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 | 12-months |
| Pattern of use of Atazanavir |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Primary care clinic
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital St Pierre | Brussels | Belgium | ||||
| German Competence Network |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
| For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 24-months |
| Pattern of use of Atazanavir | 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 | 36-months |
| Frankfurt |
| Germany |
| Italian Register for HIV-infection in Children | Florence | Italy |
| Victor Babes Hospital | Bucharest | Romania |
| Spanish Perinatal Cohort | Barcelona | Spain |
| Madrid Paediatric HIV Cohort | Madrid | Spain |
| Swiss Mother and Child HIV Cohort | Basel | Switzerland |
| Collaborative HIV Paediatric Study | London | United Kingdom |
| European Collaborative Study | London | United Kingdom |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided