Treatment of Hepatitis C in Hemophilic Patients With HIV

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C virus (HCV) infection. However, HCV infection progresses differently in patients who are coinfected with HIV and in hemophiliacs. This study will evaluate the effectiveness of PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria

• Hemophilia A or B

• Exposure to blood or blood products prior to 1987

• Participating in "The Second Multicenter Hemophilia Cohort Study (MHCS-II)"

• HCV reactive by second/third generation ELISA assay and/or RIBA

• HCV RNA positive (PCR or bDNA methods)

• Chronic hepatitis confirmed by liver biopsy within 6 months prior to study entry (Note: cirrhosis is not an exclusion factor)

• HIV infection for coinfected group; HIV viral load of 10,000 copies/ml or less

• If on antiretroviral drugs, stable regimen for at least 8 weeks prior to study entry

• Acceptable methods of contraception

Exclusion Criteria

• Hemoglobin less than 10 g/dl

• For HIV coinfected group, CD4 count less than 200 cells/mm3 at time of screening visit

• Previous interferon or ribavirin therapy

• Corticosteroids or immunomodulatory drugs within 3 months prior to study entry

• Hepatitis B (HBsAg reactive)

• Alpha-1 antitrypsin deficiency

• Wilson's disease

• Hemochromatosis

• Autoimmune disorder

• Decompensated liver disease evidenced by encephalopathy, ascites, or variceal bleed

• Prothrombin Time greater than 3 seconds above normal (International Normalized Ratio [INR] greater than 1.3)

• Platelet count less than 90,000/microL

• Active thyroid disease (thyroid replacement with normal TSH permitted)

• Chronic renal insufficiency, defined as creatinine greater than 1.5 mg/dl

• Life-threatening disease processes that could preclude completion of trial

• Alcohol abuse that the local investigator feels would interfere with compliance

• Illicit recreational drug use or methadone use within 6 months of study entry

• Major depression with hospitalization or suicide attempt is a relative, but not absolute, contraindication to therapy based on timing, circumstances, and current stability as assessed by the investigator

• Pregnant or breastfeeding