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
Mycoses, Mycobacterium Avium-Intracellulare Infection, HIV Infections
About this trial
This is an interventional treatment trial for Mycoses focused on measuring Rifabutin, Mycobacterium avium-intracellulare Infection, Mycoses, Drug Therapy, Combination, Fluconazole, Acquired Immunodeficiency Syndrome, Azithromycin
Eligibility Criteria
Inclusion Criteria 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.
Sites / Locations
- Los Angeles County - USC Med Ctr
- UCI Med Ctr
- UCSD Treatment Ctr / Dept of Medicine and Pediatrics
- Santa Clara Valley Med Ctr
- Harbor - UCLA Med Ctr
- Georgetown Univ Med Ctr
- George Washington Univ Med Ctr
- Univ of Massachusetts Med Ctr
- Univ of Pennsylvania
- Univ of Texas Southwestern Med Ctr
- Baylor College of Medicine
- Houston Veterans Administration Med Ctr