TY - JOUR
T1 - Amphotericin B lipid complex compared with amphotericin B in the treatment of cryptococcal meningitis in patients with AIDS
AU - Sharkey, Patricia K.
AU - Graybill, John R.
AU - Johnson, Edward S.
AU - Hausrath, Stephen G.
AU - Pollard, Richard B.
AU - Kolokathis, Antonia
AU - Mildvan, Donna
AU - Fan-Havard, Patty
AU - Eng, Robert H.K.
AU - Patterson, Thomas F.
AU - Pottage, John C.
AU - Simberkoff, Michael S.
AU - Wolf, Judith
AU - Meyer, Richard D.
AU - Gupta, Renu
AU - Lee, Lily W.
AU - Gordon, David S.
PY - 1996/2
Y1 - 1996/2
N2 - The study objective was to obtain preliminary information regarding the safety and efficacy of amphotericin B (AraB) 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 ≥ 12 doses. Transfusion requirements, mean decreases in hemoglobin level, and mean increases in creatinine level were significantly greater with Arab 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 ≥ 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 AraB, further evaluation of ABLC is warranted.
AB - The study objective was to obtain preliminary information regarding the safety and efficacy of amphotericin B (AraB) 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 ≥ 12 doses. Transfusion requirements, mean decreases in hemoglobin level, and mean increases in creatinine level were significantly greater with Arab 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 ≥ 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 AraB, further evaluation of ABLC is warranted.
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U2 - 10.1093/clinids/22.2.315
DO - 10.1093/clinids/22.2.315
M3 - Article
C2 - 8838189
AN - SCOPUS:9044250097
SN - 1058-4838
VL - 22
SP - 315
EP - 321
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 2
ER -