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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 response

Safety 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

Page last updated: August 23, 2015

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