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 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.
Sharkey
P K
PK
Department of Medicine, UTHSCSA, San Antonio, Texas 78284, USA.
Graybill
J R
JR
Johnson
E S
ES
Hausrath
S G
SG
Pollard
R B
RB
Kolokathis
A
A
Mildvan
D
D
Fan-Havard
P
P
Eng
R H
RH
Patterson
T F
TF
Pottage
J C
JC
Simberkoff
M S
MS
Wolf
J
J
Meyer
R D
RD
Gupta
R
R
Lee
L W
LW
Gordon
D S
DS
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*
D000935:Antifungal Agents; D004338:Drug Combinations; D010713:Phosphatidylcholines; D010715:Phosphatidylglycerols; C068538:liposomal amphotericin B; D000666:Amphotericin B