Hepatitis C, HIV Infections
Conditions
Keywords
acute hepatitis C, HIV, pegylated interferon
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.
Interventions
DRUGpegylated 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.
Sponsors
University Hospital, Bonn
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum | Week 24 |
| Normal liver enzymes | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Normal liver enzymes | Week 12 and 48 |
| Negative HCV-RNA | Week 12 and 48 |
Countries
Germany
Outcome results
None listed