A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety of Atazanavir (ATV) Capsule Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less Than 18 Years

CompletadoFase 4ClinicalTrials.gov

ID: NCT01691794Tipo: INTERVENTIONALInicio: 30 de nov de 2012Fin estimado: 20 de feb de 2017

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Confirmed HIV-1 infection diagnosed by protocol criteria
Male or female children, ≥ 6 years to \<17 years 6 months of age at the time of first treatment
Antiretroviral-naïve or treatment-experienced participants with a detectable viral load
Antiretroviral-naïve participants must have genotypic sensitivity at screening to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which have been approved for pediatric use and dosed per local country label
Antiretroviral-experienced participants must have documented genotypic and phenotypic sensitivity at screening to atazanavir (fold change in susceptibility \<2.2) and at least 2 NRTIs, which have been approved for pediatric use and dosed per local country label.

Criterios de exclusión

Experienced participants who received atazanavir with or without ritonavir at any time prior to study enrollment
Antiretroviral-naive or -experienced HIV-1 infected patients with contraindication to study medications
Documented cardiac conduction abnormality, significant cardiac dysfunction, or a history syncope
Family history of QTc interval syndrome, Brugada syndrome, right ventricular dysplasia, or a corrected QTc interval of \>440 ms at screening
One of the following cardiac rhythm abnormalities documented on the screening electrocardiogram:
First degree atrioventricular (AV) block, as defined by protocol
Type I second degree AV block while awake, type II second degree AV block at any time, complete AV block at any time, or age-adjusted heart rate \<2nd percentile
Coinfection with either hepatitis B or C virus

Intervenciones

drug

Atazanavir

drug

Ritonavir

Ubicaciones

Local Institution

Buenos Aires, Bs As, Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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