SAN FRANCISCO-Clarithromy-cin (Biaxin), a newer generation macro-lide, has been shown to have a definite favorable effect on survival when given prophylactically to patients with advanced AIDS, Mark Pierce, MD, reported at the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy.
The positive survival benefit is due primarily to clarithromy-cin's ability to prevent Mycobacterium avium complex (MAC) infection, which predicts mortality in patients with advanced HIV infection, said Dr. Pierce, associate professor of medicine and infectious diseases, Vanderbilt University School of Medicine.
Dr. Pierce presented the data for the Clarithromycin(Drug information on clarithromycin) MAC Prophylaxis Treatment Group: France, Germany, United Kingdom, and the United States, sponsored by Abbott Laboratories.
The prospective, randomized, double-blind, multicenter trial, conducted in the United States and Europe, enrolled 682 HIV-positive patients with CD4 cell counts less than 100/mm³, negative MAC blood cultures, and a life expectancy of at least 6 months. These individuals were split into two groups of 341 persons each, and randomly assigned to receive clarith-romycin, 500 mg twice daily, or placebo indefinitely.
During the study and follow-up, Dr. Pierce pointed out, 19 persons in the clarithromycin group (5.7%) developed MAC infection, compared with 53 individuals on placebo (15.9%), a 69% reduction in risk in favor of clarithromycin. (Mean time on treatment was 9.1 months for placebo patients and 10.1 months for the clarithromycin group.)
The most recent analysis shows median survival of more than 700 days in those patients who received clarithromy-cin vs 573 days in the placebo group, again a significant difference in favor of clarithromycin.
Death has occurred in 106 persons receiving clarithromycin (31%) and in 136 individuals receiving placebo (39%), for a reduction in all-cause mortality of 28% when patients were treated with clarithromycin.