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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

Tracking Information
First Submitted Date  ICMJE August 17, 2005
First Posted Date  ICMJE August 19, 2005
Last Update Posted Date October 21, 2010
Study Start Date  ICMJE September 2002
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2009)
  • Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum [ Time Frame: Week 24 ]
  • Normal liver enzymes [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2005)
Negative hepatitis C ribonucleic acid (HCV-RNA) at week 24 in peripheral serum. Normal liver enzymes at week 24.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2009)
  • Negative HCV-RNA [ Time Frame: Week 12 and 48 ]
  • Normal liver enzymes [ Time Frame: Week 12 and 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2005)
  • Negative HCV-RNA at week 12 and 48
  • Normal liver enzymes at week 12 and 48
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Official Title  ICMJE Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • HIV Infections
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 6, 2009)
200
Original Enrollment  ICMJE
 (submitted: August 17, 2005)
50
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00132210
Other Study ID Numbers  ICMJE BN-102/02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jürgen K. Rockstroh, Bonn University
Study Sponsor  ICMJE University Hospital, Bonn
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospital, Bonn
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP