Clinical trial NCT00132210: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
HIV Infections
Keywords: acute hepatitis C
HIV
pegylated interferon
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2005-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum
timeFrame: Week 24
measure: Normal liver enzymes
timeFrame: Week 24
Secondary outcomes:
measure: Negative HCV-RNA
timeFrame: Week 12 and 48
measure: Normal liver enzymes
timeFrame: Week 12 and 48
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Practice Hintsche
city: Berlin
country: Germany
facility: Practice Bieniek
city: Berlin
country: Germany
facility: Practice Dupke/Carganico/Baumgarten
city: Berlin
country: Germany
facility: Practice Schranz
city: Berlin
country: Germany
facility: Practice Freiwald/Rausch
city: Berlin
country: Germany
facility: Practice Jessen
city: Berlin
country: Germany
facility: Practice Kluschke
city: Berlin
country: Germany
facility: Ärzteforum Seestraße
city: Berlin
country: Germany
facility: Practice Center Kaiserdamm
city: Bonn
country: Germany
facility: Medical Department I, University Hospital, Bonn University
city: Hamburg
country: Germany
facility: Practice St. Georg
city: Hamburg
country: Germany
facility: Practice Fenske
city: Hamburg
country: Germany
facility: Practice Linnig
city: Stuttgart
country: Germany
facility: Practice Trein
Study officials:
affiliation: Medical Department I, University Hospital, Bonn University, Germany
name: Jürgen K Rockstroh, MD, PhD
role: STUDY_DIRECTOR
affiliation: Medical Department I, University Hospital, Bonn University
name: Martin Vogel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.