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

Study acronym: ROCO2
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Publications: 1 to 2v5
  2. Enrollment target: 50 to 17
    • Primary endpoint revised
    • Secondary endpoints revised (4)
    v4
  3. Secondary endpoints revised (4)v3
  4. Study Identification, Study Status, Conditionsv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00221650
Lead Sponsor University Hospital, Bordeaux
Collaborators: Hoffmann-La Roche, Ministry of Health, France
Conditions
(from sponsor)		 HIV Infections, Hepatitis C, Chronic, Treatment Failure
Related terms Hepatitis C, Hepatitis C, Chronic, HIV Infections
Enrollment 17 participants
Start Date
Study Completion (estimated)
Updated on ClinicalTrials.gov