Status:
COMPLETED
Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Lead Sponsor:
University Hospital, Bonn
Conditions:
Hepatitis C
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 hep...
Eligibility Criteria
Inclusion
- 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:
- known or suspected exposure to HCV,
- documented seroconversion to positivity for antibodies against HCV,
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00132210
Start Date
September 1 2002
End Date
June 1 2010
Last Update
October 21 2010
Active Locations (14)
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1
Practice Hintsche
Berlin, Germany, 10117
2
Practice Bieniek
Berlin, Germany, 10243
3
Practice Dupke/Carganico/Baumgarten
Berlin, Germany, 10439
4
Practice Schranz
Berlin, Germany, 10627