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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections Hepatitis C, Chronic Treatment Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Peginterferon alfa2a

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Didier Neau, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pellegrin, 33076 Bordeaux Cedex, France

Genevieve Chene, Pr

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

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Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD

Bordeaux, , France

Site Status

Countries

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France

References

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Thiebaut R, Guedj J, Jacqmin-Gadda H, Chene 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. doi: 10.1186/1471-2288-6-38.

Reference Type BACKGROUND

PMID: 16879756 (View on PubMed)

Other Identifiers

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2000-023

Identifier Type: -

Identifier Source: secondary_id

9232-01