translation agency

NLM AIDSLINE
Amphotericin B lipid complex compared with amphotericin B in the treatment of cryptococcal meningitis in patients with AIDS [see comments]
Sharkey PK; Graybill JR; Johnson ES; Hausrath SG; Pollard RB; Kolokathis
February 28, 1997
Clin Infect Dis. 1996 Feb;22(2):315-21. Unique Identifier : AIDSLINE

The study objective was to obtain preliminary information regarding the safety and efficacy of amphotericin B (AmB) lipid complex (ABLC) in the treatment of AIDS-associated cryptococcal meningitis. Of 55 patients randomly assigned to 6 weeks of therapy with ABLC (1.2-5.0 mg/[kg.d], with ascending doses for three sequential cohorts) or AmB (0.7-1.2 mg/[kg.d]), 46 received > or = 12 doses. Transfusion requirements, mean decreases in hemoglobin level, and mean increases in creatinine level were significantly greater with AmB than with ABLC. The total number of adverse events, infusion-related events, and occurrences of hypomagnesemia and hypokalemia associated with each form of therapy were similar. Among 21 recipients of ABLC at a dosage of 5 mg/kg (daily for 2 weeks and then thrice weekly for 4 weeks), symptoms and signs resolved for 18 (86%). Of those receiving > or = 12 doses of ABLC, cultures converted to negative for 8 (42%), were undeterminable for 3 (16%), and remained positive for 8 (42%) despite resolution of symptoms. Although preliminary, these data suggest ABLC has significant activity in patients with AIDS-associated cryptococcal meningitis. Because this formulation has less hematologic and renal toxicity than does AmB, further evaluation of ABLC is warranted.

Adult Amphotericin B/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Antibiotics, Antifungal/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Antifungal Agents/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE AIDS-Related Opportunistic Infections/*DRUG THERAPY Cohort Studies Comparative Study Drug Combinations Female Human Male Meningitis, Cryptococcal/*DRUG THERAPY Middle Age Phosphatidylcholines/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Phosphatidylglycerols/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Support, Non-U.S. Gov't CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL

www.aegis.org