7th Conference on Retroviruses and Opportunistic Infections
 


Prevention of Opportunistic Infections Other than Mycobacterium avium Complex (MAC) in a Randomized, Placebo-Controlled Trial of Azithromycin (AZ) Prophylaxis in Subjects with Increases in CD4 Cells on Antiretroviral Therapy (ART) - Preliminary Results

S. L. KOLETAR1 *, J. S. CURRIER2, P. L. WILLIAMS3, R. HAFNER4, R. L. MURPHY5, S. COHN6, C. KNIRSCH7, T. NEVIN8, and J. A. MCCUTHCHAN9 for the ACTG 362 TEAM. 1Ohio State Univ., Columbus; 2Univ. of California Los Angeles; 3Harvard Sch. of Publ. Hlth., Boston, MA; 4NIAID, Bethesda, MD; 5Northwestern Univ., Chicago, IL; 6Univ. of Rochester, NY; 7Pfizer, New York, NY; 8AACTG Operations Ctr., Rockville, MD; and 9Univ. of California, San Diego

Background: Recent reports suggest that specific prophylaxis for MAC can be safely discontinued in patients (pts) who sustain ART-induced increases in CD4 counts. Whether this benefit extends to other opportunistic infections is less clear.
Methods: In a prospective, placebo-controlled randomized trial, pts with increases in CD4 cells from <50 cells/mm3 to >100/mm3 received weekly AZ 1200 mg or placebo. Clinical evaluations were performed every 8 wks. Follow-up is continuing.
Results: 643 pts (322 AZ, 321 placebo) were enrolled over 20 months (median follow-up 15.8 months). Baseline characteristics were comparable.  As of 10/1/99, 36 pts (14 AZ, 22 Placebo; p=NS) had at least one infection.  Serious infections other than MAC that may possibly be prevented by azithromycin were verified, and included 27 bacterial infections, 5 PCP, and 1 pt with an enteric protozoal infection.              

There were 10 deaths  (3 AZ, 7 placebo). Differences in infections and deaths were not statistically different between groups.
Conclusions: Opportunistic infections other than MAC are relatively infrequent but still occur in this once severely immunosuppressed population. No significant differences were detectable from these preliminary results, but the rates of these serious infections were low for this duration of follow-up. The long-term impact of discontinuing azithromycin on the incidence of infections other than MAC remains to be seen.

Key Words: azithromycin, bacterial infections, prophylaxis

 

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