Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With HIV

TerminadoFase 3ClinicalTrials.gov

ID: NCT01866930Tipo: INTERVENTIONALInicio: 11 de jul de 2013Fin estimado: 27 de ago de 2015

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1

Descripción detallada

Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics GT=genotype

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

HCV Genotype-1, -2, -3 or -4 treatment naïve;
HCV RNA ≥10,000 IU/mL at screening;
HIV-1 infection \[(approximately 200 subjects receiving HAART, approximately 100 subjects not receiving highly active antiretroviral therapy (HAART)\];
For subjects receiving HAART, HIV RNA must be below \<40 copies/mL at screening and \<200 copies/mL for at least 8 weeks prior to screening;
CD4 cell count at screening must be ≥100 cells/μL if receiving HAART or ≥350 cells/μL if not receiving HAART)
Seronegative for Hepatitis B Surface Antigen (HBsAg)
Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI=weight (kg)/\[height (m)\]2 at screening;
Subjects with compensated cirrhosis are permitted, but the number of subjects will be capped at approximately 30%. If a subject does not have cirrhosis, a liver biopsy within 3 years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. Fibroscan® or FibroTest are acceptable if performed within 1 year prior to treatment in countries where liver biopsy is not required prior to treatment and where non-invasive imaging tests are approved for staging of liver disease
Subjects with mild to moderate hemophilia as defined as:
Mild-factor level activity of 6-4% OR
Moderate defined as factor level activity of 1-5%

Criterios de exclusión

Any evidence of liver disease other than chronic HCV;
Subjects infected with human immunodeficiency virus (HIV-2);
Diagnosed or suspected hepatocellular carcinoma;
Decompensated liver disease;
Presence of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 weeks prior to study entry (AIDS-defining opportunistic infections as defined by the CDC, (CDC, JAMA 1993 Feb 10;269(6):729-30)
Laboratory values: ANC \<1.5 x 109 cells/L (\<1.2 x 109 cells/L for Blacks), platelet count \<90 x 109 cells/L, hemoglobin \<11 g/dL for females, hemoglobin \<12 g/dL for males;
Subjects (receiving HAART) who had first initiated anti-retroviral therapy within last 8 weeks prior to Day 1; however, if changes are required to a subject's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. Subjects should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, \<40 copies/mL
Subjects on Zidovudine (AZT), Didanosine (ddI), or Stavudine (d4T);
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Subjects with severe hemophilia (defined as \<1% factor activity level)

Intervenciones

biological

Pegylated Interferon Lambda-1a

drug

Daclatasvir (DCV)

drug

Ribasphere (RBV)

Ubicaciones

Local Institution

Buenos Aires, Bs As, Buenos Aires, Argentina

Local Institution

Mar del Plata, Buenos Aires, Argentina

Local Institution

Quilmes, Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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