Estudio de fase 3, abierto, de seguridad y eficacia de BMS-790052 más interferón pegilado alfa 2a y ribavirina en pacientes sin tratamiento previo con VHC coinfectados con virus de la inmunodeficiencia humana (VIH) y virus de la hepatitis C (VHC)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01471574Tipo: INTERVENTIONALInicio: 1 de dic de 2011Fin estimado: 1 de sept de 2014

Gastroenterología Enfermedades Infecciosas Alergia e Inmunología

Resumen

El propósito de este estudio abierto es evaluar la seguridad y eficacia de daclatasvir más interferón pegilado alfa 2a y ribavirina en pacientes con virus de la hepatitis C sin tratamiento previo, coinfectados con VIH.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Males and females, 18 to 70 years of age
Hepatitis C virus (HCV) genotype 1a or 1b
HCV-treatment naive
HCV RNA \>10,000 IU/mL at screening
HIV-1 infection (approximately 250 patients receiving highly active antiretroviral therapy \[HAART\], up to 50 patients not receiving HAART)
For patients receiving HAART, HIV RNA must be below \<40 copies/mL at screening and must be \<400 copies/ml for at least 6 months prior to screening

Criterios de exclusión

Patients receiving HAART who first initiated antiretroviral therapy within the last 6 months of Day 1
Patients receiving HAART who have changed their antiretroviral regimen due to safety or efficacy associated to HIV treatment within the last 3 months prior to Day 1. However, if changes are required to a patient's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. The patient should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, \<40 copies/ mL
Use of prohibited HAART regimens within 1 month of Day 1 and throughout the treatment period of the trial (patients receiving HAART who have changed their antiretroviral regimen to initiate any HCV treatment within 6 weeks prior to Day 1)
Laboratory values:
Neutrophil count \<1500 cells/μL (\<1200 cells/ μL for Blacks)
Platelet count \<90,000 cells/μL
Hemoglobin ≤12 g/dL for females, hemoglobin ≤13 g/dL for males
Total bilirubin ≥34 μmol/L (or ≥2 mg/dL) unless a patient has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir
Alanine aminotransferase ≥5\*upper limit of normal

Intervenciones

drug

Daclatasvir

Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks

drug

Ribavirin

Tablets; oral; for patients weighing \<75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing \>75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response

drug

PEG-Interferon alfa 2a

Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Prov de Santa Fe, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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