Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus
Condition: Hepatitis C, Genotype 1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Daclatasvir; Ribavirin; PEG-Interferon alfa 2a
Intervention description: Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks; 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; Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 549.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir
      plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients
      coinfected with HIV
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Key Inclusion Criteria:

          -  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

        Key Exclusion Criteria:

          -  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:

               1. Neutrophil count <1500 cells/μL (<1200 cells/ μL for Blacks)

               2. Platelet count <90,000 cells/μL

               3. Hemoglobin ≤12 g/dL for females, hemoglobin ≤13 g/dL for males

               4. 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

               5. Alanine aminotransferase ≥5*upper limit of normal