BACKGROUND. It is generally acknowledged that
amphotericin B is the most effective treatment for
cryptococcal meningitis. However, administration of this
drug is accompanied by substantial adverse effects. This double-blind study, performed before the routine availability of
highly active antiretroviral therapy, was designed to compare the efficacy and safety of
liposomal amphotericin B to conventional
amphotericin deoxycholate in patients with
acquired immunodeficiency syndrome (
AIDS) and acute
cryptococcal meningitis. METHODS. Patients were randomized (ratio, 1:1:1) from multiple sites in the United States and Canada to receive either
amphotericin B at 0.7 mg/kg/day (n = 87),
liposomal amphotericin B at 3 mg/kg/day (n = 86), or
liposomal amphotericin B at 6 mg/kg/day (n = 94). RESULTS. Efficacy was similar among all 3 treatment groups. The overall incidence of infusion-related reactions was significantly lower for both the 3 mg/kg/day and 6 mg/kg/day dosages of
liposomal amphotericin B, compared with conventional
amphotericin B (P < .001). Significantly fewer patients who received the 3 mg/kg/day dosage of
liposomal amphotericin B developed nephrotoxicity, indicated by a doubling of the serum
creatinine value, compared with recipients of conventional
amphotericin B (P = .004). Overall mortality
at 10 weeks was 11.6%, with no significant differences among the treatment groups. CONCLUSIONS.
Liposomal amphotericin B provides an equally efficacious alternative to conventional
amphotericin B deoxycholate in patients with
AIDS and acute
cryptococcal meningitis.
Liposomal amphotericin B at a dosage of 3 mg/kg/day is accompanied by significantly fewer adverse effects.