Clinical Trial: Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial (PERFECT)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Pilot, Open-Label, Multicentre Study Evaluating the Long-Term Safety and Tolerability of a Low-Dose Peginterferon Alfa-2a Maintenance Monotherapy in Chronic Hepatitis C Patients Co-Infected With Hum

Brief Summary: This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA) after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety and tolerability. Secondary objectives are to evaluate histological, virological, and biochemical effects.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Percentage of Participants with Adverse Events (AEs) [ Time Frame: From Baseline to end of treatment (up to 18 months) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of Participants with Histological Response According to Paired Biopsy [ Time Frame: At end of treatment (up to 18 months) ]
  • HIV RNA Viral Load in Copies per Milliliter (copies/mL) [ Time Frame: At end of treatment (up to 18 months) ]
  • Cluster of Differentiation (CD) 4 Cell Count in Cells per Microliter (cells/mcL) [ Time Frame: At end of treatment (up to 18 months) ]
  • Percentage of Participants with Virological Response According to HCV RNA Viral Load [ Time Frame: At 6, 12, and 18 months during treatment, and at 24 weeks after end of treatment (up to 2 years overall) ]
  • Percentage of Participants with Biochemical Response According to Alanine Aminotransferase (ALT) Level [ Time Frame: At end of treatment (up to 18 months) ]
  • Percentage of Participants with Sustained Biochemical Response According to ALT Level [ Time Frame: At 24 weeks after end of treatment (up to 2 years overall) ]


Original Secondary Outcome: Same as current

Information By: Hoffmann-La Roche

Dates:
Date Received: May 3, 2016
Date Started: March 2005
Date Completion:
Last Updated: September 6, 2016
Last Verified: May 2016