A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

Concurrent Medication:

Allowed:

• Preventive therapy with isoniazid for M. tuberculosis.
• Maintenance therapy for CMV retinitis.

Patients must have:

• HIV infection or history of an AIDS-defining condition by CDC criteria.
• One documented CD4 count \< 100 cells/mm3 within 12 months prior to study entry.
• NO active MAC disease, MAC bacteremia, or active mycobacterial infection (tuberculous or nontuberculous).
• NO acute opportunistic infection.
• Life expectancy of more than 6 months.
• Consent of parent or guardian if less than legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

ALL PATIENTS -

• Unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver function tests, or odynophagia for which the diagnoses of MAC and fungal infections have not been excluded.
• Serious hypersensitivity reactions to macrolides or rifampin.
• Unable to tolerate oral medications. FOR FLUCONAZOLE RANDOMIZATION -
• Serious hypersensitivity reaction to fluconazole.
• Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, Candida esophagitis, thrush, vaginal candidiasis).
• Positive baseline urine cryptococcal culture.

Concurrent Medication:

Excluded for fluconazole randomization:

• Maintenance therapy for deep fungal infections.
• Chronic therapy with ketoconazole or fluconazole.