HIV Infections Clinical Trial
Official title:
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
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. ;
Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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