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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00132210
First received: August 17, 2005
Last updated: October 20, 2010
Last verified: November 2009
  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
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    Drug: pegylated interferon
    Pegylated interferon alfa-2a or -2b in standard dosage Ribavirin in case of genotype 1 or 4 at 1000 or 1200 mg/d according to body weight ist recommended.
    Other Names:
    • Pegasys
    • PegIntron
    • Copegus
    • Rebetol
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Practice Jessen
Berlin, Germany, 10777
Practice Center Kaiserdamm
Berlin, Germany, 14057
Practice Dupke/Carganico/Baumgarten
Berlin, Germany, 10439
Practice Freiwald/Rausch
Berlin, Germany, 10777
Practice Hintsche
Berlin, Germany, 10117
Ärzteforum Seestraße
Berlin, Germany, 13347
Practice Kluschke
Berlin, Germany, 12047
Practice Bieniek
Berlin, Germany, 10243
Practice Schranz
Berlin, Germany, 10627
Medical Department I, University Hospital, Bonn University
Bonn, Germany, 53127
Practice Fenske
Hamburg, Germany, 20146
Practice Linnig
Hamburg, Germany, 20359
Practice St. Georg
Hamburg, Germany, 20099
Practice Trein
Stuttgart, Germany, 70197
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

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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Infection
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014