title: Amphotericin B lipid complex compared with amphotericin B in the treatment of cryptococcal meningitis in patients with AIDS.
abstract: 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.
authors.affiliation: Department of Medicine, UTHSCSA, San Antonio, Texas 78284, USA.
authors.forename: P K
authors.initials: PK
authors.lastname: Sharkey
authors.forename: J R
authors.initials: JR
authors.lastname: Graybill
authors.forename: E S
authors.initials: ES
authors.lastname: Johnson
authors.forename: S G
authors.initials: SG
authors.lastname: Hausrath
authors.forename: R B
authors.initials: RB
authors.lastname: Pollard
authors.forename: A
authors.initials: A
authors.lastname: Kolokathis
authors.forename: D
authors.initials: D
authors.lastname: Mildvan
authors.forename: P
authors.initials: P
authors.lastname: Fan-Havard
authors.forename: R H
authors.initials: RH
authors.lastname: Eng
authors.forename: T F
authors.initials: TF
authors.lastname: Patterson
authors.forename: J C
authors.initials: JC
authors.lastname: Pottage
authors.forename: M S
authors.initials: MS
authors.lastname: Simberkoff
authors.forename: J
authors.initials: J
authors.lastname: Wolf
authors.forename: R D
authors.initials: RD
authors.lastname: Meyer
authors.forename: R
authors.initials: R
authors.lastname: Gupta
authors.forename: L W
authors.initials: LW
authors.lastname: Lee
authors.forename: D S
authors.initials: DS
authors.lastname: Gordon
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D016919:Meningitis, Cryptococcal / Q000188:drug therapy*; D008875:Middle Aged; D010713:Phosphatidylcholines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010715:Phosphatidylglycerols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000935:Antifungal Agents; D004338:Drug Combinations; D010713:Phosphatidylcholines; D010715:Phosphatidylglycerols; C068538:liposomal amphotericin B; D000666:Amphotericin B