Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 28
- Primary Endpoint
- Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum
Time Frame: Week 24
Normal liver enzymes
Time Frame: Week 24
Secondary Outcomes
- Negative HCV-RNA(Week 12 and 48)
- Normal liver enzymes(Week 12 and 48)