AMPHOTERICIN-B LIPID COMPLEX COMPARED WITH AMPHOTERICIN-B IN THE TREATMENT OF CRYPTOCOCCAL MENINGITIS IN PATIENTS WITH AIDS

The study objective was to obtain preliminary information regarding th e safety and efficacy of amphotericin B (AmB) lipid complex (ABLC) in the treatment of AIDS-associated cryptococcal meningitis. Of 55 patien ts 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 greater than or equal to 12 doses. Transfu sion requirements, mean decreases in hemoglobin level, and mean increa ses 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 fo rm 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), sympt oms and signs resolved for 18 (86%), Of those receiving greater than o r equal to 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 sugge st ABLC has significant activity in patients with AIDS-associated cryp tococcal meningitis, Because this formulation has less hematologic and renal toxicity than does AmB, further evaluation of ABLC is warranted .