Objective: To determine the safety and efficacy of liposomal amphoteri
cin B (AmBisome) in the primary treatment of AIDS-associated cryptococ
cosis. Design: A Phase II, multicentre, European, non-comparative, ope
n study to assess the use of AmBisome in 23 patients (26 enrolments) w
ith cryptococcosis. Dose requirements, mycological response and toxici
ty were documented. Setting; Hospital-based HIV units. Patients: Twent
y-three HIV-1-seropositive patients. Results: Drug toxicity, assessed
in 25 enrolments, was well-tolerated with little renal, hepatic or hae
matological toxicity. Eighteen out of 23 (78%) enrolments responded cl
inically. Nineteen enrolments had cryptococcal meningitis: sterilizati
on of spinal fluid was achieved in 12 out of the 18 (67%) who were myc
ologically evaluable. Fourteen out of the 19 (74%) responded clinicall
y. Conclusion: AmBisome is well-tolerated and may be an effective form
ulation in the treatment of cryptococcosis.