A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1
Condition: Hepatitis C Virus Genotype-1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of TMC435 along with
      pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C
      virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and
      to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after
      the planned end of treatment.
    

Detailed description: 
      This is an open-label (all the people know the identity of the intervention), single arm
      (study will be conducted in a single group) clinical study, to evaluate the safety,
      tolerability and efficacy of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and
      ribavirin (RBV) triple therapy in adult chronic hepatitis C (CHC) genotype-1 infected
      patients who are co-infected with human immunodeficiency virus-type 1 (HIV-1). The study
      consists of 3 phases, screening phase (Week -6), treatment phase, and a follow-up phase (up
      to 24 weeks). In the treatment phase, patients will be classified based on their experience
      with previous hepatitis C virus (HCV) treatment as follows: 1) HCV treatment-naive (patients
      who never received medication for the treatment of HCV); 2) prior HCV relapsers (patients who
      received at least 24 weeks of a PegIFNα-2a and RBV-based therapy and relapsed within 1 year
      after the last medication intake); and 3) prior HCV non-responders (can be further classified
      as, null responders: patients having at least 1 prior documented course of PegIFNα-2a and RBV
      therapy for at least 12 consecutive weeks; or partial responders: patients having at least 20
      consecutive weeks which has not been discontinued due to intolerability to PegIFNα-2a and RBV
      therapy). All patients will receive TMC435 once daily along with PegIFNα-2a and RBV for 12
      weeks. Patients who are continuing treatment only with PegIFNα-2a and RBV will follow until
      24 or 48 weeks. Pharmacokinetics will be measured after collection of blood samples. Safety
      evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs,
      physical examinations, and specific toxicities will be performed throughout the study. The
      total duration of treatment is approximately of 24 weeks.
    

Intervention name(s): TMC435; Pegylated interferon alpha-2a; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.; Pegylated interferon alpha-2a 180 microgram will be administered as subcutaneous injection of 0.5 mL until 24 to 48 weeks.; Ribavirin 1000 or 1200 mg twice daily will be administered each day until 24 to 48 weeks.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Simeprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C virus genotype-1; Human immunodeficiency virus-type 1; HCV-1; HIV-1; TMC435; Pegylated interferon alpha-2a; PegIFNα-2a; Pegasys; Ribavirin; RBV; Copegus