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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.

Abstract
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.
AuthorsRichard J Hamill, Jack D Sobel, Wafaa El-Sadr, Philip C Johnson, John R Graybill, Kedarnath Javaly, David E Barker
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 51 Issue 2 Pg. 225-32 (Jul 15 2010) ISSN: 1537-6591 [Electronic] United States
PMID20536366 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antifungal Agents
  • Drug Combinations
  • liposomal amphotericin B
  • Deoxycholic Acid
  • Amphotericin B
  • amphotericin B, deoxycholate drug combination
  • Creatinine
Topics
  • AIDS-Related Opportunistic Infections (drug therapy)
  • Adolescent
  • Adult
  • Aged
  • Amphotericin B (administration & dosage, adverse effects)
  • Antifungal Agents (administration & dosage, adverse effects)
  • Canada
  • Child
  • Creatinine (blood)
  • Deoxycholic Acid (administration & dosage, adverse effects)
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Kidney Diseases (chemically induced)
  • Male
  • Meningitis, Cryptococcal (drug therapy, mortality)
  • Middle Aged
  • Treatment Outcome
  • United States
  • Young Adult

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