A Phase III Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of TMC435 Plus PegIFNα-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Subjects Who Are Co-infected With Human Immunodeficiency Virus Type 1 (HIV-1)

Trial Profile

A Phase III Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of TMC435 Plus PegIFNα-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Subjects Who Are Co-infected With Human Immunodeficiency Virus Type 1 (HIV-1)

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Dec 2014

At a glance

  • Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C; HIV-1 infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 18 Oct 2013 Results were presented at the European AIDS Conference (EACS) in October 2013, and were reported in a Medivir media release.
    • 01 Aug 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
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