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

NCT00296972 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2007-04-23

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Hepatitis C
  • HIV Infections

Interventions

DRUG

peg interferon plus ribavirin

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Curtis Cooper, MD · The Ottawa Hospital, On

  • Marianne Harris, MD · St. Paul's Hospital, Vancouver B.C

  • Marina Klein, MD · Hopital Royal-Victoria/Institut Thoracique de Montreal,Que

  • Mark Poliquin, MD · Clinique Médicale L'Actuel

  • Steve Shafran, MD · University of Alberta Hospital, AB

  • Anita Rachlis, MD · Sunnybrook & Women's College HSC, On

  • Chris Fraser, MD · Victoria, BC

  • Val Montessori, MD · St. Paul's Hospital, Vancouver B.C

  • Benoit Trottier, MD · Clinique Medicale L'Actuel, Que

  • John Farley, MD · Winnepeg, MB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Completion
2007-04-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00296972 on ClinicalTrials.gov