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

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ClinicalTrials.gov Identifier: NCT00132210
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : October 21, 2010
Sponsor:
Information provided by:
University Hospital, Bonn

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C HIV Infections Drug: pegylated interferon Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Study Start Date : September 2002
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arms and Interventions
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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

Outcome Measures
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Primary Outcome Measures :
  1. Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum [ Time Frame: Week 24 ]
  2. Normal liver enzymes [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Negative HCV-RNA [ Time Frame: Week 12 and 48 ]
  2. Normal liver enzymes [ Time Frame: Week 12 and 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132210


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

Other Publications:

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Responsible Party: Jürgen K. Rockstroh, Bonn University
ClinicalTrials.gov Identifier: NCT00132210    
Other Study ID Numbers: BN-102/02
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: October 21, 2010
Last Verified: November 2009
Keywords provided by University Hospital, Bonn:
acute hepatitis C
HIV
pegylated interferon
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents