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Clarithromycin for disseminated Mycobacterium avium-complex in AIDS patients.
Chaisson RE; Benson CA; Dube M; Hafner R; Dellerson M; Lichter S; Smith
December 30, 1992
Int Conf AIDS. 1992 Jul 19-24;8(1):We54 (abstract no. WeB 1052). Unique

OBJECTIVE: To determine the efficacy and safety of clarithromycin (CLR) therapy for disseminated MAC disease in patients with AIDS. METHODS: Multicenter, randomized, double-blind, dose ranging study. Patients received CLR 500 mg, 1000 mg, or 2000 mg BID for 12 weeks. Quantitative mycobacterial blood cultures were performed at entry and regularly during follow up. RESULTS: 108 patients have been entered. An interim analysis was performs after the first 72 patients (24/arm) completed 12 weeks of therapy. Demographic and clinical features of patients at entry were similar. Bacteriologic results are shown in the Table. TABULAR DATA, SEE ABSTRACT VOLUME. The median percent reduction from baseline CFU at 12 weeks was 100%, 99.5%, and 99.4%. Median times to eradication were 55 days (500 mg), 43 days (1000 mg), and 27 days (2000 mg; p = .04). Fevers and night sweats improved in 76%, 47%, and 75% of patients. Discontinuation due to adverse events occurred in 3 patients (500 mg), 2 patients (1000 mg), and 11 patients (2000 mg). The predominant adverse event was GI upset. In vitro resistance (MIC greater than 4 mcg/ml) to CLR developed in 16 patients. CONCLUSION: CLR is highly active against MAC infection in patients with AIDS. A dose-response effect was observed, but toxicity was more common at 2000 mg BID. Emergence of resistance suggests the need for combination therapy.

Acquired Immunodeficiency Syndrome/*COMPLICATIONS Comparative Study Dose-Response Relationship, Drug Double-Blind Method Drug Resistance, Microbial Erythromycin/*ANALOGS & DERIVATIVES/ADMINISTRATION & DOSAGE/ ADVERSE EFFECTS/THERAPEUTIC USE Human Mycobacterium avium-intracellulare Infection/COMPLICATIONS/*DRUG THERAPY Safety ABSTRACT