A Prospective Single Arm, Open-label, International, Mult... | EligiMed

A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in Human Immunodeficiency Virus (HIV) Infected, Antiretroviral, Naive and Experienced Pediatric Subjects From 3 Months to Less Than 11 Years.(Pediatric Atazanavir International Clinical Evaluation: the PRINCE II Study)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01335698Tipo: INTERVENTIONALInicio: 27 de may de 2011Fin estimado: 22 de ene de 2018

Enfermedades Infecciosas Pediatría Alergia e Inmunología

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to \<11 years.

Elegibilidad

Edad mínima: 3 MonthsEdad máxima: 11 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Confirmed HIV-1 infection diagnosed by protocol criteria
Screening HIV RNA level ≥1000 copies/mL
≥3 months to \<11 years of age at time of first treatment
Antiretroviral-naive or -experienced
At screening, all participants must have genotypic sensitivity to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which must be approved for pediatric use at the local country.
Antiretroviral-experienced patients must also have documented phenotypic sensitivity at screening to atazanavir (Fold Change in susceptibility \<2.2) and to at least 2 NRTIs that are approved in their country

Criterios de exclusión

Experienced participants who received atazanavir or atazanavir/ritonavir at any time prior to study enrollment or who have a history of 2 or more protease inhibitor failures
Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to study medications
Cardiac rhythm abnormalities
Need for tenofovir
Weight \<5 or ≥35kg
\>Grade 2 abnormality in aspartate transaminase/alanine transaminase levels
Coinfection with either hepatitis B or C virus
Any active Centers for Disease Control and Prevention Category C clinical condition

Intervenciones

drug

Atazanavir Sulphate

drug

Ritonavir

Ubicaciones

Local Institution

Buenos Aires, Bs As, Buenos Aires, Argentina

Local Institution

Bunos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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