The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 contin...

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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.

Trial Officials