the safety and effectiveness of a two-drug combination in the treatment of patients with hepatitis c plus advanced hiv infections

Conditions: HIV Infections; Hepatitis C

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.

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.

Eligibility criteria:
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.

Keywords: aids-related opportunistic infections interferon alfa-2b zalcitabine didanosine drug therapy, combination acquired immunodeficiency syndrome zidovudine hepatitis c