Safety and efficacy of high-dose infusions of a preformed amphotericin B fat emulsion for treatment of Indian visceral leishmaniasis

Am J Trop Med Hyg. 2009 May;80(5):700-3.

Abstract

Amphotericin B deoxycholate is used as a first-line drug for visceral leishmaniasis (VL) in India. Its major drawbacks are prolonged hospitalization of treated patients and toxicity. An open label phase II study with pre-formed amphotericin B lipid emulsion (ABLE) was conducted to evaluate safety and efficacy of four regimens of 15 mg/kg each administered in 1-2 doses. Regimen 1 was 7.5 mg/kg/day on day 1 and day 3, and regimen 4 was a single bolus infusion of 15 mg/kg. The safety profile was excellent with mild infusion reactions seen in 38% of the patients. Definitive cure was achieved in 100% of the patients treated with regimen 4. The overall cure rate was 87% (95% confidence interval = 75-94%). In this study, ABLE was safe and had excellent efficacy when given as a bolus of 15 mg/kg. More studies with larger number of patients and higher doses are needed to establish acceptable, safe and efficacious regimen.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Amphotericin B / administration & dosage*
  • Amphotericin B / adverse effects
  • Amphotericin B / therapeutic use*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Emulsions
  • Female
  • Humans
  • India
  • Leishmaniasis, Visceral / drug therapy*
  • Lipids / chemistry
  • Male
  • Young Adult

Substances

  • Emulsions
  • Lipids
  • Amphotericin B