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Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-infected Patients

NCT00221650 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-05-15

No results posted yet for this study

Summary

Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.

Conditions

  • HIV Infections
  • Hepatitis C, Chronic
  • Treatment Failure

Interventions

DRUG

Peginterferon alfa2a

DRUG

Ribavirin

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Didier Neau, MD-PhD · Hôpital Pellegrin, 33076 Bordeaux Cedex, France

  • Genevieve Chene, Pr · University Hospital, Bordeaux

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Completion
2004-06-30

Countries

  • France

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 NCT00221650 on ClinicalTrials.gov