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

• Status: Completed
• Trial end date: 1996-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Schering-Plough
• Treatments: Didanosine; Interferon alpha-2; Interferon-alpha; Interferons; Zalcitabine; Zidovudine

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.