A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals

Inclusion Criteria

Concurrent Medication:

Allowed:

• Stable maintenance or prophylaxis therapy for opportunistic infection, if such therapy was administered for at least 30 days prior to study entry.
• Isoniazid for chemoprophylaxis against Mycobacterium tuberculosis.
• Fluconazole for mucosal candidiasis or cryptococcosis.
• Acyclovir (up to 1.0 g/day).
• Dapsone.
• Ketoconazole.
• Quinolones.
• Tetracycline.
• Vitamins and herbal therapies.
• Antibiotics as clinically indicated.
• Systemic corticosteroids for < 21 days for acute problems.
• Regularly prescribed medications.

Patients must have:

• HIV positivity by ELISA confirmed by Western blot.
• CD4 count < 500 cells/mm3 within 30 days prior to study entry.
• No active opportunistic infections requiring treatment (patients on stable maintenance and prophylaxis therapy for opportunistic infections for at least 30 days are permitted).

NOTE:

• Enrollment of women is encouraged.

Prior Medication:

Allowed:

• Prior stable maintenance or prophylaxis therapy for opportunistic infection, if administered for at least 30 days prior to study entry.

Exclusion Criteria

Concurrent Medication:

Excluded:

• Concurrent rifampin or rifabutin.
• Other anti-HIV drugs and investigational agents.
• Biological response modifiers.
• Ganciclovir or foscarnet.
• Systemic cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

• Concurrent radiation therapy other than limited localized therapy to the skin.

Patients with the following prior conditions are excluded:

• History of peripheral neuropathy.
• History of pancreatitis or active liver disease.

Prior Medication:

Excluded:

• Prior ddI.
• Ribavirin within 60 days prior to study entry.
• AZT or ddC within 2 weeks prior to study entry.

Prior Treatment:

Excluded:

• Transfusion within 2 weeks prior to study entry.

Active alcohol abuse.