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

August 17, 2005
October 20, 2010
September 2002
June 2010   (final data collection date for primary outcome measure)
  • 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 hepatitis C ribonucleic acid (HCV-RNA) at week 24 in peripheral serum. Normal liver enzymes at week 24.
Complete list of historical versions of study NCT00132210 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Negative HCV-RNA at week 12 and 48.
  • Normal liver enzymes at week 12 and 48.
Not Provided
Not Provided
 
Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients

The purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • HIV Infections
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00132210
BN-102/02
No
Jürgen K. Rockstroh, Bonn University
University Hospital, Bonn
Not Provided
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
University Hospital, Bonn
November 2009

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