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