title: Once weekly azithromycin therapy for prevention of Mycobacterium avium complex infection in patients with AIDS: a randomized, double-blind, placebo-controlled multicenter trial.
abstract: We conducted a randomized, double-blind, placebo-controlled multicenter trial of azithromycin (1,200 mg once weekly) for the prevention of Mycobacterium avium complex (MAC) infection in patients with AIDS and a CD4 cell count of < 100/mm3. In an intent-to-treat analysis through the end of therapy plus 30 days, nine (10.6%) of 85 azithromycin recipients 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 azithromycin for the five breakthrough (first) MAC isolates from the azithromycin group and the 18 breakthrough MAC isolates from the placebo group. Of the 76 patients who died during the study, four (10.5%) of 38 azithromycin recipients and 12 (31.6%) of 38 placebo recipients had a MAC infection followed by death (P = .025). For deaths due to all causes, there was no difference in time to death or number of deaths between the two groups. Episodes of non-MAC bacterial infection per 100 patient years occurred in 43 azithromycin recipients and 88 placebo recipients (relative risk, 0.49; 95% confidence interval, 0.33-0.73). The most common toxic effect noted during the study was gastrointestinal, reported by 78.9% of azithromycin recipients and 27.5% of placebo recipients. Azithromycin given once weekly is safe and effective in preventing disseminated MAC infection, death due to MAC infection, and respiratory tract infections in patients with AIDS and CD4 cell counts of < 100/mm3.
authors.affiliation: Naval Hospital, San Diego, California, USA.
authors.forename: E C
authors.initials: EC
authors.lastname: Oldfield
authors.forename: W J
authors.initials: WJ
authors.lastname: Fessel
authors.forename: M W
authors.initials: MW
authors.lastname: Dunne
authors.forename: G
authors.initials: G
authors.lastname: Dickinson
authors.forename: M R
authors.initials: MR
authors.lastname: Wallace
authors.forename: W
authors.initials: W
authors.lastname: Byrne
authors.forename: R
authors.initials: R
authors.lastname: Chung
authors.forename: K F
authors.initials: KF
authors.lastname: Wagner
authors.forename: S F
authors.initials: SF
authors.lastname: Paparello
authors.forename: D B
authors.initials: DB
authors.lastname: Craig
authors.forename: G
authors.initials: G
authors.lastname: Melcher
authors.forename: M
authors.initials: M
authors.lastname: Zajdowicz
authors.forename: R F
authors.initials: RF
authors.lastname: Williams
authors.forename: J W
authors.initials: JW
authors.lastname: Kelly
authors.forename: M
authors.initials: M
authors.lastname: Zelasky
authors.forename: L B
authors.initials: LB
authors.lastname: Heifets
authors.forename: J D
authors.initials: JD
authors.lastname: Berman
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D015270:Mycobacterium avium-intracellulare Infection / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control*; D017741:Survivors
chemical_list: D000900:Anti-Bacterial Agents; D017963:Azithromycin