Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-Infected Patients - Full Text View

Sponsored by:	University Hospital, Bonn
Information provided by:	University Hospital, Bonn
ClinicalTrials.gov Identifier:	NCT00132210

Purpose

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	Drug: pegylated interferon	Phase IV

MedlinePlus related topics: AIDS Hepatitis Hepatitis C

Drug Information available for: Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-Infected Patients

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:

Negative hepatitis C ribonucleic acid (HCV-RNA) at week 24 in peripheral serum
Normal liver enzymes at week 24

Secondary Outcome Measures:

Negative HCV-RNA at week 12 and 48
Normal liver enzymes at week 12 and 48

Estimated Enrollment:	50
Study Start Date:	September 2002
Estimated Study Completion Date:	June 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132210

Contacts

Contact: Jürgen K Rockstroh, MD, PhD	+49-228-287 ext 6558	juergen.rockstroh@ukb.uni-bonn.de
Contact: Martin Vogel, MD	+49-228-287 ext 6558	martin.vogel@ukb.uni-bonn.de

Locations

Germany
Medical Department I, University Hospital, Bonn University	Recruiting
Bonn, Germany, 53127
Contact: Martin Vogel, MD +49-228-287 ext 6558 martin.vogel@ukb.uni-bonn.de
Principal Investigator: Martin Vogel, MD
Sub-Investigator: Jan-Christian Wasmuth, MD
Principal Investigator: Jürgen K Rockstroh, MD
Sub-Investigator: Carolynne Schwarze-Zander, MD
Practice Jessen	Recruiting
Berlin, Germany, 10777
Contact: Heiko Jessen, MD +49-30-2351070
Principal Investigator: Heiko Jessen, MD
Sub-Investigator: Arne Jessen, MD
Practice St. Georg	Recruiting
Hamburg, Germany, 20099
Contact: Knud Schewe, MD +49-40-28050528
Principal Investigator: Knud Schewe, MD
Practice Bieniek	Recruiting
Berlin, Germany, 10243
Contact: Bernhard Bieniek, MD +49-30-29363950
Principal Investigator: Bernhard Bieniek, MD
Sub-Investigator: Christiane Cordes, MD
Ärzteforum Seestraße	Recruiting
Berlin, Germany, 13347
Contact: Christoph Mayr, MD +49-30-4550950
Principal Investigator: Christoph Mayr, MD
Sub-Investigator: Wolfgang Schmidt, MD, PhD
Practice Schranz	Recruiting
Berlin, Germany, 10627
Contact: Dietmar Schranz, MD +49-30-8929488
Principal Investigator: Dietmar Schranz, MD
Practice Dupke/Carganico/Baumgarten	Recruiting
Berlin, Germany, 10439
Contact: Axel Baumgarten, MD +49-30-4467730
Principal Investigator: Axel Baumgarten, MD
Sub-Investigator: Stephan Dupke, MD
Sub-Investigator: Andreas Carganico, MD
Practice Hintsche	Recruiting
Berlin, Germany, 10117
Contact: Bettina Hintsche, MD +49-30-2825052
Principal Investigator: Bettina Hintsche, MD
Practice Fenske	Recruiting
Hamburg, Germany, 20146
Contact: Stefan Fenske, MD +49-40-4132420
Principal Investigator: Stefan Fenske, MD
Practice Kluschke	Recruiting
Berlin, Germany, 12047
Contact: Michael Kluschke, MD +49-30-6233033
Principal Investigator: Michael Kluschke, MD
Practice Linnig	Recruiting
Hamburg, Germany, 20359
Contact: Stefan Linnig, MD +49-40-35715638
Principal Investigator: Stefan Linnig, MD
Practice Center Kaiserdamm	Recruiting
Berlin, Germany, 14057
Contact: Gerd Klausen, MD +49-30-3011390
Principal Investigator: Gerd Klausen, MD
Sub-Investigator: Arend Moll, MD
Sub-Investigator: Jörg Gölz, MD
Sub-Investigator: Kevin Ummard
Practice Trein	Recruiting
Stuttgart, Germany, 70197
Contact: Andreas Trein, MD +49-711-6155320
Principal Investigator: Andreas Trein, MD
Practice Freiwald/Rausch	Recruiting
Berlin, Germany, 10777
Contact: Michael Rausch, MD +49-30-21967650
Principal Investigator: Michael Rausch, MD

Sponsors and Collaborators

University Hospital, Bonn

Investigators

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

More Information

Interim results of the ongoing study This link exits the ClinicalTrials.gov site

Publications:

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.

Rockstroh JK, Vogel M. Therapy of hepatitis C in HIV-coinfection. Eur J Med Res. 2004 Jun 30;9(6):304-8. Review.

Study ID Numbers:	BN-102/02
Study First Received:	August 17, 2005
Last Updated:	October 19, 2005
ClinicalTrials.gov Identifier:	NCT00132210
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Bonn:

acute hepatitis C
HIV
pegylated interferon

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
HIV Infections

Interferons
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Hepatitis C

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents

Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009