This multicenter, randomized, dose-ranging study was performed to determine
the safety and efficacy of two different doses of azithromycin for treatin
g disseminated Mycobacterium avium complex (MAC) in patients with AIDS. Eig
hty-eight AIDS patients with symptoms and blood cultures consistent with di
sseminated MAC were treated with 600 or 1,200 mg of azithromycin daily for
6 weeks; 62 patients completed the entire 6 weeks of study, Of note, this s
tudy was done prior to the time when combination antiretroviral or anti-MAC
regimens were the standard of care. Over the 6-week study period, symptoma
tic improvement was noted in both dose groups, Microbiological responses we
re comparable, with mean decreases of 1.5 and 2.0 log CFU/ml in the high- a
nd low-dose groups, respectively, Sterilization of blood cultures occurred
in 54% of samples; patients with lower baseline colony counts were more lik
ely to achieve culture negativity, Resistance developed in one patient. Gas
trointestinal symptoms were the most common side effects and were more freq
uent in patients receiving 1,200 mg. Azithromycin is a useful alternative t
reatment for disseminated MAC infection in AIDS patients. Symptomatic impro
vement correlates with measurable decreases in mycobacterial load.