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

NCT00132210 | Completed Phase 4

• 1 other identifier: BN-102/02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 14

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.

Conditions

Hepatitis C; HIV Infections

Keywords

acute hepatitis C; HIV; pegylated interferon

Outcome Measures

Primary Outcomes (2)

• Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum

  Week 24

• Normal liver enzymes

  Week 24

Secondary Outcomes (2)

• Negative HCV-RNA

  Week 12 and 48

• Normal liver enzymes

  Week 12 and 48

Interventions

pegylated interferon DRUG

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.

Also known as: Pegasys, PegIntron, Copegus, Rebetol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• known or suspected exposure to HCV,
• documented seroconversion to positivity for antibodies against HCV,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (14)

Practice Hintsche

Berlin, 10117, Germany

Location

Practice Bieniek

Berlin, 10243, Germany

Location

Practice Dupke/Carganico/Baumgarten

Berlin, 10439, Germany

Location

Practice Schranz

Berlin, 10627, Germany

Location

Practice Freiwald/Rausch

Berlin, 10777, Germany

Location

Practice Jessen

Berlin, 10777, Germany

Location

Practice Kluschke

Berlin, 12047, Germany

Location

Ärzteforum Seestraße

Berlin, 13347, Germany

Location

Practice Center Kaiserdamm

Berlin, 14057, Germany

Location

Medical Department I, University Hospital, Bonn University

Bonn, 53127, Germany

Location

Practice St. Georg

Hamburg, 20099, Germany

Location

Practice Fenske

Hamburg, 20146, Germany

Location

Practice Linnig

Hamburg, 20359, Germany

Location

Practice Trein

Stuttgart, 70197, Germany

Location

Related Publications (2)

• 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. doi: 10.1111/j.1365-2893.2005.00580.x.

  PMID: 15720537 BACKGROUND

• Vogel M, Nattermann J, Baumgarten A, Klausen G, Bieniek B, Schewe K, Jessen H, Boesecke C, Rausch M, Lutz T, Fenske S, Schranzo D, Kummerle T, Schuler C, Theisen A, Mayr C, Seidel T, Rockstroh JK. Pegylated interferon-alpha for the treatment of sexually transmitted acute hepatitis C in HIV-infected individuals. Antivir Ther. 2006;11(8):1097-101.

  PMID: 17302380 RESULT

MeSH Terms

Conditions

Hepatitis C; HIV Infections

Interventions

peginterferon alfa-2a; peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jürgen K Rockstroh, MD, PhD

  Medical Department I, University Hospital, Bonn University, Germany

  STUDY DIRECTOR

• Martin Vogel, MD

  Medical Department I, University Hospital, Bonn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 19, 2005
• Study Start: September 1, 2002
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 21, 2010

Record last verified: 2009-11

Locations

DE (14)