ONCE WEEKLY AZITHROMYCIN THERAPY FOR PREVENTION OF MYCOBACTERIUM-AVIUM COMPLEX INFECTION IN PATIENTS WITH AIDS - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER TRIAL

We conducted a randomized, double-blind, placebo-controlled multicente r trial of azithromycin (1,200 mg once weekly) for the prevention of M ycobacterium avium complex (MAC) infection in patients with AIDS and a CD4 cell count of <100/mm(3), In an intent-to-treat analysis through the end of therapy plus 30 days, nine (10.6%) of 85 azithromycin recip ients and 22 (24.7%) of 89 placebo recipients developed MAC infection (hazard ratio, 0.34; P = .004), There was no difference in the ranges of minimal inhibitory concentrations of either clarithromycin or azith romycin for the five breakthrough (first) MAC isolates from the azithr omycin group and the 18 breakthrough MAC isolates from the placebo gro up, Of the 76 patients who died during the study, four (10.5%) of 38 a zithromycin recipients and 12 (31.6%) of 38 placebo recipients had a M AC infection followed by death (P = .025), For deaths due to all cause s, there was no difference in time to death or number of deaths betwee n the two groups, Episodes of non-MAC bacterial infection per 100 pati ent years occurred in 43 azithromycin recipients and 88 placebo recipi ents (relative risk, 0.49; 95% confidence interval, 0.33-0.73), The mo st common toxic effect noted during the study was gastrointestinal, re ported by 78.9% of azithromycin recipients and 27.5% of placebo recipi ents, Azithromycin given once weekly is safe and effective in preventi ng disseminated MAC infection, death due to MAC infection, and respira tory tract infections in patients with AIDS and CD4 cell counts of <10 0/mm(3).