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

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.