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NLM AIDSLINE
Controlled trial of clarithromycin/ethambutol with or without clofazimine for Mycobacterium avium complex bacteremia in AIDS.
Chaisson RE; Keiser P; Pierce M; Fessel WJ; Ruskin J; Lahart C; Meek K;
November 30, 1996
3rd Conf Retro and Opportun Infect. 1996 Jan 28-Feb 1;:164. Unique

To compare the efficacy of a 2- and 3-drug regimen for treating MAC bacteremia, 106 AIDS patients with MAC were treated with clarithromycin (CLR) 0.5 g bid, ethambutol (EMB) 15 mg/kg/d and were randomized to receive clofazimine (CLO) 100 mg/d or no CLO. Baseline blood cultures were positive in 89. The proportion becoming culture negative was 65% in the 2-drug group and 54% in the 3-drug group. The median time to negative culture was 58 days for 2-drug patients and 63 days for 3-drug patients. At the end of treatment, the mean reduction in log CFUs of MAC was 1.8 for 2-drug patients and 2.3 for 3-drug patients. One patient had a baseline MIC greater than 8 and one patient developed resistance during therapy. Improvement in fever and night sweats was reported by 87% of 2-drug patients and 84% of 3-drug patients. The proportion of patients withdrawn for adverse events was 13% in the 2-drug group and 22% in the 3-drug group. 38% of 2-drug patients and 61% of 3-drug patients died (p=0.03), and time to death was shorter in patients treated with 3 drugs (p=0.01). CLR/EMB is effective in treating MAC bacteremia and preventing resistance. The addition of CLO does not contribute to clinical response and is associated with higher mortality.

Acquired Immunodeficiency Syndrome/*COMPLICATIONS Anti-Infective Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Bacteremia Clarithromycin/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Clofazimine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Ethambutol/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Human Mycobacterium avium-intracellulare Infection/BLOOD/COMPLICATIONS/ *DRUG THERAPY ABSTRACT

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