Liposomal amphotericin B (AmBisome) in the treatment of complicated kala-azar under field conditions

Clin Infect Dis. 1995 Jul;21(1):188-93. doi: 10.1093/clinids/21.1.188.

Abstract

An open trial of liposomal amphotericin B (AmBisome [L-AmB]; Vestar, San Dimas, CA) for treatment of complicated visceral leishmaniasis was performed in Sudan. Forty-nine patients were treated, and there were six deaths (12% mortality); these were not attributed to therapy. Thirty-seven patients were selected for the trial because of (1) relapse after treatment with a combination of pentavalent antimony (Sbv) and aminosidine, (2) incomplete parasitological response to Sbv and aminosidine, or (3) severe illness. Drug regimen 1 (3 doses of 3-5 mg/kg, on days 0, 3, and 10) cured 8 (50%) of 16 patients; regimen 2 (6 doses of 3-5 mg/kg, on days 0, 3, 6, 8, 10, and 13) cured 14 (88%) of 16. For four of 10 partial responders, "rescue" therapy with L-AmB alone (3 mg/kg daily for 10 days) resulted in cure. Twelve less-unwell patients received regimen 3 (4 doses of 4-5 mg/kg, on days 0, 2, 5, and 7); seven of 11 patients evaluated (64%) were cured. The optimal regimen of L-AmB in these circumstances is administration of 4 mg/kg on days 0, 3, 6, 8, 10, and 13.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Amebicides / therapeutic use
  • Amphotericin B / administration & dosage*
  • Amphotericin B / adverse effects
  • Animals
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / adverse effects
  • Antimony / therapeutic use
  • Child
  • Child, Preschool
  • Drug Administration Schedule
  • Drug Carriers
  • Female
  • Humans
  • Infant
  • Leishmania donovani / isolation & purification
  • Leishmania infantum / isolation & purification
  • Leishmaniasis, Visceral / drug therapy*
  • Leishmaniasis, Visceral / etiology
  • Leishmaniasis, Visceral / mortality
  • Liposomes
  • Lymph Nodes / parasitology
  • Male
  • Middle Aged
  • Paromomycin / therapeutic use
  • Recurrence
  • Spleen / parasitology
  • Sudan

Substances

  • Amebicides
  • Anti-Bacterial Agents
  • Drug Carriers
  • Liposomes
  • Paromomycin
  • Amphotericin B
  • Antimony