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

Primary Purpose

Hepatitis C, HIV Infections

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
pegylated interferon
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring acute hepatitis C, HIV, pegylated interferon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 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

Sites / Locations

  • Practice Hintsche
  • Practice Bieniek
  • Practice Dupke/Carganico/Baumgarten
  • Practice Schranz
  • Practice Freiwald/Rausch
  • Practice Jessen
  • Practice Kluschke
  • Ärzteforum Seestraße
  • Practice Center Kaiserdamm
  • Medical Department I, University Hospital, Bonn University
  • Practice St. Georg
  • Practice Fenske
  • Practice Linnig
  • Practice Trein

Outcomes

Primary Outcome Measures

Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum
Normal liver enzymes

Secondary Outcome Measures

Negative HCV-RNA
Normal liver enzymes

Full Information

First Posted
August 17, 2005
Last Updated
October 20, 2010
Sponsor
University Hospital, Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT00132210
Brief Title
Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Official Title
Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bonn

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, HIV Infections
Keywords
acute hepatitis C, HIV, pegylated interferon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegylated interferon
Other Intervention Name(s)
Pegasys, PegIntron, Copegus, Rebetol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum
Time Frame
Week 24
Title
Normal liver enzymes
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Negative HCV-RNA
Time Frame
Week 12 and 48
Title
Normal liver enzymes
Time Frame
Week 12 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen K Rockstroh, MD, PhD
Organizational Affiliation
Medical Department I, University Hospital, Bonn University, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin Vogel, MD
Organizational Affiliation
Medical Department I, University Hospital, Bonn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Practice Hintsche
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Practice Bieniek
City
Berlin
ZIP/Postal Code
10243
Country
Germany
Facility Name
Practice Dupke/Carganico/Baumgarten
City
Berlin
ZIP/Postal Code
10439
Country
Germany
Facility Name
Practice Schranz
City
Berlin
ZIP/Postal Code
10627
Country
Germany
Facility Name
Practice Freiwald/Rausch
City
Berlin
ZIP/Postal Code
10777
Country
Germany
Facility Name
Practice Jessen
City
Berlin
ZIP/Postal Code
10777
Country
Germany
Facility Name
Practice Kluschke
City
Berlin
ZIP/Postal Code
12047
Country
Germany
Facility Name
Ärzteforum Seestraße
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Practice Center Kaiserdamm
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
Medical Department I, University Hospital, Bonn University
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Practice St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Practice Fenske
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
Practice Linnig
City
Hamburg
ZIP/Postal Code
20359
Country
Germany
Facility Name
Practice Trein
City
Stuttgart
ZIP/Postal Code
70197
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15720537
Citation
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.
Results Reference
background
PubMed Identifier
17302380
Citation
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.
Results Reference
result

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

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