PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population. SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. To compare survival and outcomes of primary endpoints in the treatment arms.
Patients are randomized to receive azithromycin alone, rifabutin alone, or the two drugs in combination for MAC prophylaxis. Patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis, unless specifically excluded for fluconazole randomization. Patients are followed for 1 to 2 years.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
720
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCI Med Ctr
Orange, California, United States
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
San Diego, California, United States
Santa Clara Valley Med Ctr
San Jose, California, United States
Harbor - UCLA Med Ctr
Torrance, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States
...and 2 more locations
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