Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients
Information source: University Hospital, Bordeaux
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Hepatitis C, Chronic; Treatment Failure
Intervention: Peginterferon alfa2a (Drug); Ribavirin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Hospital, Bordeaux Official(s) and/or principal investigator(s): Didier Neau, MD-PhD, Principal Investigator, Affiliation: Hôpital Pellegrin, 33076 Bordeaux Cedex, France Genevieve Chene, Pr, Study Chair, Affiliation: University Hospital, Bordeaux
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.
Clinical Details
Official title: Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level
Secondary outcome: Proportion of patients with a virological responseSafety of treatment Influence of anti-HCV treatment on CD4 count and HIV RNA Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or
interferon combined with ribavirin, Elevated ALT level
- HIV infection (CD4>250/µL, HIV RNA<10 000 copies/ml) treated or not with
antiretroviral therapy
- Signed informed consent
Exclusion Criteria:
- Chronic hepatitis B
- Alcohol consumption>40g/day
- Evidence of decompensated liver disease
- Hepatocellular carcinoma
- Other relevant disorders: organ transplantation, psychiatric or cardiovascular
disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune
disease
Locations and Contacts
Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD, Bordeaux 33076, France
Additional Information
Related publications: Thiébaut R, Guedj J, Jacqmin-Gadda H, Chêne G, Trimoulet P, Neau D, Commenges D. Estimation of dynamical model parameters taking into account undetectable marker values. BMC Med Res Methodol. 2006 Aug 1;6:38.
Starting date: April 2002
Last updated: June 12, 2007
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