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

Phase 4

Completed

• Conditions: Hepatitis C; HIV Infections

• Registration Number: NCT00132210
• Lead Sponsor: University Hospital, Bonn

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-08-17
• Study First Submitted QC: 2005-08-17
• Study First Posted: 2005-08-19
• Status Verified: 2009-11
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-10-20
• Last Update Posted: 2010-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum	Week 24
Normal liver enzymes	Week 24

Secondary Outcome Measures

Name	Time	Method
Negative HCV-RNA	Week 12 and 48
Normal liver enzymes	Week 12 and 48

Trial Locations

Locations (14)

Practice Trein; 🇩🇪 Stuttgart, Germany

Practice Hintsche; 🇩🇪 Berlin, Germany

Practice Bieniek; 🇩🇪 Berlin, Germany

Practice Dupke/Carganico/Baumgarten; 🇩🇪 Berlin, Germany

Practice Jessen; 🇩🇪 Berlin, Germany

Practice Schranz; 🇩🇪 Berlin, Germany

Practice Kluschke; 🇩🇪 Berlin, Germany

Practice Freiwald/Rausch; 🇩🇪 Berlin, Germany

Ärzteforum Seestraße; 🇩🇪 Berlin, Germany

Practice Center Kaiserdamm; 🇩🇪 Berlin, Germany

Practice St. Georg; 🇩🇪 Hamburg, Germany

Practice Fenske; 🇩🇪 Hamburg, Germany

Practice Linnig; 🇩🇪 Hamburg, Germany

Medical Department I, University Hospital, Bonn University; 🇩🇪 Bonn, Germany