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

September 6, 2016 updated by: Hoffmann-La Roche

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 Human Immunodeficiency Virus and Who Do Not Respond to a Standard Regimen of Peginterferon Alfa-2a Plus Ribavirin

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1020
      • Bruxelles, Belgium, 1070
      • Bruxelles, Belgium, 1200
      • Bruxelles, Belgium, 1000
      • Bruxelles, Belgium, 1090
      • Charleroi, Belgium, 6000
      • Edegem, Belgium, 2650
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
      • Liege, Belgium, 4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Serologic evidence of chronic hepatitis C infection by anti-HCV antibody test
  • Received peginterferon alfa-2a for at least 12 weeks and either did not reach a 2-log drop in HCV RNA after 12 weeks of treatment, did not reach an undetectable HCV RNA after 24 weeks of treatment, or reached undetectable HCV RNA that was detectable again at the end of 48 weeks of treatment
  • Detectable serum HCV RNA at Screening
  • Serologic evidence of HIV infection by HIV RNA detection
  • CD4 cell count greater than or equal to (>/=) 100 cells/mcL during therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
  • Stable HIV status and, if on antiretroviral therapy, a stable regimen for at least 6 weeks prior to Baseline
  • Compensated liver disease
  • No evidence of hepatocellular carcinoma

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Antineoplastic or immunomodulatory treatment within 6 months prior to first dose
  • Any investigational drug within 6 weeks prior to first dose
  • Positive for hepatitis A immunoglobulin M antibody
  • Severe neutropenia or thrombocytopenia at Screening while still on therapy with peginterferon alfa-2a plus ribavirin
  • Severe psychiatric or neurologic comorbidity
  • History of any significant medical conditions, such as immune disorders or disease of the major organ systems
  • Uncontrolled thyroid disease
  • Severe retinopathy
  • Evidence of drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peginterferon Alfa-2a
Participants will receive a low dose of peginterferon alfa-2a for 18 months.
Drug: Peginterferon Alfa-2
Peginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly.
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Histological Response According to Paired Biopsy
Time Frame: At end of treatment (up to 18 months)
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)
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)
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)
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)
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)
At 24 weeks after end of treatment (up to 2 years overall)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18234
  • 2004-002736-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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