Journal Article

Comparison of 2 Doses of Liposomal Amphotericin B and Conventional Amphotericin B Deoxycholate for Treatment of AIDS-Associated Acute Cryptococcal Meningitis: A Randomized, Double-Blind Clinical Trial of Efficacy and Safety

Richard J. Hamill, Jack D. Sobel, Wafaa El-Sadr, Philip C. Johnson, John R. Graybill, Kedarnath Javaly, David E. Barker and Carol J. Baker

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 51, issue 2, pages 225-232
Published in print July 2010 | ISSN: 1058-4838
Published online July 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/653606
Comparison of 2 Doses of Liposomal Amphotericin B and Conventional Amphotericin B Deoxycholate for Treatment of AIDS-Associated Acute Cryptococcal Meningitis: A Randomized, Double-Blind Clinical Trial of Efficacy and Safety

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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.

Journal Article.  4282 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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