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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132210
• Other study ID #: BN-102/02
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2005
• Last updated: October 20, 2010
• Start date: September 2002
• Est. completion date: June 2010

Study information

• Verified date: November 2009
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV Infections
• Infection

Intervention

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.

Locations

Country	Name	City	State
Germany	Ärzteforum Seestraße	Berlin
Germany	Practice Bieniek	Berlin
Germany	Practice Center Kaiserdamm	Berlin
Germany	Practice Dupke/Carganico/Baumgarten	Berlin
Germany	Practice Freiwald/Rausch	Berlin
Germany	Practice Hintsche	Berlin
Germany	Practice Jessen	Berlin
Germany	Practice Kluschke	Berlin
Germany	Practice Schranz	Berlin
Germany	Medical Department I, University Hospital, Bonn University	Bonn
Germany	Practice Fenske	Hamburg
Germany	Practice Linnig	Hamburg
Germany	Practice St. Georg	Hamburg
Germany	Practice Trein	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & 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. — View 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, Kümmerle T, Schuler C, Theisen A, Mayr C, Seidel T, Rockstroh JK. Pegylated interferon-alpha for the treatment of sexually t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum		Week 24	No
Primary	Normal liver enzymes		Week 24	No
Secondary	Negative HCV-RNA		Week 12 and 48	No
Secondary	Normal liver enzymes		Week 12 and 48	No