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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bonn
• Treatments: Interferons

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