Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication

April 19, 2007 updated by: University Health Network, Toronto

A Randomized, Multicenter, phaseIIIB, Two Arm Study Evaluating the Tolerability of Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Infection co-Infected With Human Immunodeficiency Virus Receiving HAART Versus Not Receiving HAART

The main purpose of this study is to compare the safety, effectiveness and tolerability of using Pegasys with Copegus in people who have both the hepatitis C virus (HCV) genotype 1 and HIV who continue taking HAART (highly active antiretroviral therapy) to those who discontinue taking HAART.

Canadian guidelines recommend that both HIV and HCV should not be treated at the same time as the medications needed to treat these two diseases may interact and that which disease to treat first is dependent on the CD4 count. In this study, the CD4 count must be over 350 cells and one must be stable on HAART before starting the study medication Pegasys in combination with Copegus.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Since the introduction of highly active antiretroviral therapies (HAART), liver disease secondary to HCV infection has become a leading cause of morbidity and mortality in HIV/HCV co-infection. The influence of HCV co-infection on the progression of HIV has been less clear and the results have been conflicting. Studies conducted in the pre-HAART era did not find that HIV/HCV co-infection influenced the progression of HIV-induced immunodeficiency or death. Of four large studies conducted after HAART was introduced, two suggested a faster progression of HIV disease in the presence of HCV co-infection and two found no influence of HCV co-infection on overall mortality or progression of HIV disease. HCV may also negatively influence HIV disease in indirect ways, such as making the discontinuation of antiretroviral treatment more frequent because of an increased risk of liver toxicity.The morbidity and mortality resulting from the rapid progression of HCV infection in HIV-co-infected patients, particularly given the advances in HIV treatment that have improved the life expectancy of HIV-infected patients, support treating HCV infection in these patients.

Study Type

Interventional

Enrollment

100

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network, Toronto General Hospital

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:

  • Hepatitis C genotype 1 infection·
  • Detectable plasma HCV-RNA Roche>1000copies/ml, >600IU/ml
  • Chronic liver disease consistent with CHC infection on a biopsy obtained within the past 24 months
  • Patients with cirrhosis or incomplete cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP <100 ng/mL within 2 months of randomization
  • Patients with CD4 cell count ³ 350 cells /µL
  • Patients on stable highly active antiretroviral therapy (HAART) for at least 12 weeks prior to baseline with the exception of patients receiving didanosine
  • HIV-1 RNA is < 5000 copies/mL

Exclusion Criteria:

  • IFN, pegylated interferons, viramidine, levovirin, or ribavirin therapy at any previous time
  • Patients with evidence of active hepatitis B infection. ( presence of HbsAg)
  • History or evidence of decompensated liver disease and/or a Child-Pugh score > 5, bleeding from esophageal varices, hepatic malignancy
  • abnormal bloodwork ie absolute neutrophil <1,Hbg <110, Platelets <70,creatinine <50

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the safety and tolerability of PEG-IFN with ribavirin in HIV/HCV co-infected patients who continue HAART therapy compared to those who discontinue HAART therapy in the first 12 weeks

Secondary Outcome Measures

Outcome Measure
To compare the sustained virological response.

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Collaborators

Hoffmann-La Roche

Investigators

  • Study Director: Curtis Cooper, MD, The Ottawa Hospital, On
  • Study Director: Marianne Harris, MD, St. Paul's Hospital, Vancouver B.C
  • Study Director: Marina Klein, MD, Hopital Royal-Victoria/Institut Thoracique de Montreal,Que
  • Study Director: Mark Poliquin, MD, Clinique médicale l'Actuel
  • Study Director: Steve Shafran, MD, University of Alberta Hospital, AB
  • Study Director: Anita Rachlis, MD, Sunnybrook & Women's College HSC, On
  • Study Director: Chris Fraser, MD, Victoria, BC
  • Study Director: Val Montessori, MD, St. Paul's Hospital, Vancouver B.C
  • Study Director: Benoit Trottier, MD, Clinique Medicale L'Actuel, Que
  • Study Director: John Farley, MD, Winnepeg, MB

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

July 1, 2005

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 23, 2007

Last Update Submitted That Met QC Criteria

April 19, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML 18562A

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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