Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients

NCT ID: NCT00132210

Last Updated: 2010-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.

Detailed Description

Background:HIV-infected individuals are at higher risk of developing a chronic course of hepatitis C after infection. Moreover, chronic hepatitis C is less well treatable in HIV-Coinfected than in hepatitis C monoinfected patients. There is basic research and clinical data on hepatitis C mono-infection supporting high sustained response rates of hepatitis C when treatment is started in the acute phase of infection.

Aim of the study: To determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.

Methods: Prospective, open-label, historical controlled trial. Eligible subjects are treated over 24 weeks with a pegylated interferon at standard dose. Weight-adjusted ribavirin comedication is recommended for HCV-genotypes 1 and 4. Treatment will be withheld for 12 weeks in order to allow spontaneous resolution in subjects with clinical symptomatic hepatitis C infection.

Conditions

Hepatitis C; HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

pegylated interferon

Pegylated interferon alfa-2a or -2b in standard dosage Ribavirin in case of genotype 1 or 4 at 1000 or 1200 mg/d according to body weight ist recommended.

Intervention Type: DRUG

Other Intervention Names

Pegasys; PegIntron; Copegus; Rebetol

Eligibility Criteria

Inclusion Criteria

• Documented acute hepatitis C infection with detectable HCV-RNA (PCR-assay) and elevated serum alanine transferase (ALT) levels. An acute infection is defined by fulfilling two of the following 3 criteria within the preceding four months:

1. known or suspected exposure to HCV,

2. documented seroconversion to positivity for antibodies against HCV,

3. a serum alanine transferase (ALT) level of more than 350 U/l with a documented normal level during the year before infection.

• Documented HIV-infection
• CD4 cells > 300 /µl
• Ability to understand and sign a written consent form
• Women of child-bearing age: negative pregnancy test

Exclusion Criteria

• Autoimmune hepatitis or other autoimmune disease
• Decompensated liver disease
• Decompensated renal disease, i.e. creatinine clearance < 50 ml/min, according to Cockcroft-Gault
• Acute or chronic hepatitis B infection
• Acute infection with hepatitis A or other hepatotropic viruses
• New AIDS defining event less than 1 month prior to enrolment
• Malignancy other than cutaneous kaposi sarcoma treated with systemic chemo-therapy
• History of severe psychiatric conditions, in particular severe depression
• History of seizures
• History of organ transplantation
• Thyroid disease not medically compensable
• Severe heart disease
• Severe retinopathy
• Known allergy to the study drug or one of the galenic compounds
• Hypersensitivity to interferon a
• Thrombocytes < 90 G/l, neutrophils < 1.5 G/l, hemoglobin must not be < 12g/dl (female) or < 13 g/dl (male)
• Treatment with corticosteroids less than 3 months prior to enrolment
• Alcohol abuse or use of other recreational drugs
• Older than 65 years of age, younger than 18 years of age
• Pregnancy, breast-feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Bonn University

Principal Investigators

Jürgen K Rockstroh, MD, PhD

Role: STUDY_DIRECTOR

Medical Department I, University Hospital, Bonn University, Germany

Martin Vogel, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Department I, University Hospital, Bonn University

Locations

Practice Hintsche

Berlin, , Germany

Practice Bieniek

Berlin, , Germany

Practice Dupke/Carganico/Baumgarten

Berlin, , Germany

Practice Schranz

Berlin, , Germany

Practice Freiwald/Rausch

Berlin, , Germany

Practice Jessen

Berlin, , Germany

Practice Kluschke

Berlin, , Germany

Ärzteforum Seestraße

Berlin, , Germany

Practice Center Kaiserdamm

Berlin, , Germany

Medical Department I, University Hospital, Bonn University

Bonn, , Germany

Practice St. Georg

Hamburg, , Germany

Practice Fenske

Hamburg, , Germany

Practice Linnig

Hamburg, , Germany

Practice Trein

Stuttgart, , Germany

Countries

Germany

References

Vogel M, Bieniek B, Jessen H, Schewe CK, Hoffmann C, Baumgarten A, Kroidl A, Bogner JR, Spengler U, Rockstroh JK. Treatment of acute hepatitis C infection in HIV-infected patients: a retrospective analysis of eleven cases. J Viral Hepat. 2005 Mar;12(2):207-11. doi: 10.1111/j.1365-2893.2005.00580.x.

Reference Type: BACKGROUND

PMID: 15720537 (View on PubMed)

Vogel M, Nattermann J, Baumgarten A, Klausen G, Bieniek B, Schewe K, Jessen H, Boesecke C, Rausch M, Lutz T, Fenske S, Schranzo D, Kummerle T, Schuler C, Theisen A, Mayr C, Seidel T, Rockstroh JK. Pegylated interferon-alpha for the treatment of sexually transmitted acute hepatitis C in HIV-infected individuals. Antivir Ther. 2006;11(8):1097-101.

Reference Type: RESULT

PMID: 17302380 (View on PubMed)

Other Identifiers

BN-102/02

Identifier Type: -

Identifier Source: org_study_id