Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
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The purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C HIV Infections |
Drug: pegylated interferon |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients |
- Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Normal liver enzymes [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Negative HCV-RNA [ Time Frame: Week 12 and 48 ] [ Designated as safety issue: No ]
- Normal liver enzymes [ Time Frame: Week 12 and 48 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 200 |
Study Start Date: | September 2002 |
Study Completion Date: | June 2010 |
Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
-
Drug: pegylated interferon
- Pegasys
- PegIntron
- Copegus
- Rebetol
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
- 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 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
Germany | |
Practice Jessen | |
Berlin, Germany, 10777 | |
Practice Bieniek | |
Berlin, Germany, 10243 | |
Ärzteforum Seestraße | |
Berlin, Germany, 13347 | |
Practice Kluschke | |
Berlin, Germany, 12047 | |
Practice Dupke/Carganico/Baumgarten | |
Berlin, Germany, 10439 | |
Practice Hintsche | |
Berlin, Germany, 10117 | |
Practice Schranz | |
Berlin, Germany, 10627 | |
Practice Center Kaiserdamm | |
Berlin, Germany, 14057 | |
Practice Freiwald/Rausch | |
Berlin, Germany, 10777 | |
Medical Department I, University Hospital, Bonn University | |
Bonn, Germany, 53127 | |
Practice Linnig | |
Hamburg, Germany, 20359 | |
Practice Fenske | |
Hamburg, Germany, 20146 | |
Practice St. Georg | |
Hamburg, Germany, 20099 | |
Practice Trein | |
Stuttgart, Germany, 70197 |
Study Director: | Jürgen K Rockstroh, MD, PhD | Medical Department I, University Hospital, Bonn University, Germany |
Principal Investigator: | Martin Vogel, MD | Medical Department I, University Hospital, Bonn University |
Publications:
Responsible Party: | Jürgen K. Rockstroh, Bonn University |
ClinicalTrials.gov Identifier: | NCT00132210 History of Changes |
Other Study ID Numbers: | BN-102/02 |
Study First Received: | August 17, 2005 |
Last Updated: | October 20, 2010 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital, Bonn:
acute hepatitis C HIV pegylated interferon |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Interferons Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on March 03, 2013