Hepatitis C, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, Interferon Alfa-2b, Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Hepatitis C
Brief summary
To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nucleoside analog therapy. IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.
Detailed description
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined. Patients receive interferon alpha-2b subcutaneously 3 times weekly for 6 months. If no response is seen after 18 weeks of therapy or if an initial response is followed by relapse while on therapy, dose is increased. Patients who require a dose escalation should continue on IFN alfa-2b for an additional 6 months. All patients will also receive available nucleoside analog therapy ( zidovudine, didanosine, zalcitabine ) at currently accepted doses as clinically appropriate.
Interventions
DRUGInterferon alfa-2b
DRUGZidovudine
DRUGZalcitabine
DRUGDidanosine
Sponsors
Schering-Plough
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Treatment or suppression of opportunistic infections with standard drugs. * Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines. * Clinically indicated antibiotics. * Short courses of steroids (\< 21 days) for acute problems not related to hepatitis C. * Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives. Patients must have: * HIV positivity. * Documented hepatitis C virus. * CD4 count \<= 200 cells/mm3. * No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C. * Willingness to be followed for the duration of treatment and follow-up period. Prior Medication: Allowed: * Prior AZT, ddI, and ddC.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Hepatitis B (HBsAg positive). * Autoimmune hepatitis (FANA titer \>= 1:160 and anti-smooth muscle antibody titer \>= 1:160). * Wilson's disease. * alpha-1 antitrypsin deficiency. * Hemochromatosis. * Malignancy requiring systemic chemotherapy. Concurrent Medication: Excluded: * Nonnucleoside analog therapy for HIV. * Biologic response modifiers. * Systemic cytotoxic chemotherapy. * Chronic systemic steroid use. Concurrent Treatment: Excluded: * Radiation therapy other than local irradiation to the skin. Prior Medication: Excluded: * Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration). * Acute therapy for an infection within 2 weeks prior to study entry.
Countries
United States
Outcome results
None listed