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.