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Ambisome plus miltefosine for Indian patients with kala-azar.

Abstract
The combination of one intravenous administration of 5mg/kg Ambisome and oral administration of miltefosine, 2.5mg/kg/day for 14 days, was evaluated in 135 Indian patients with kala-azar. The Intent-to-Treat cure rate at 6 months was 124 of the 135 enrolled patients (91.9%: 95% CI = 86-96%), and the per protocol cure rate was 124 of 127 evaluable patients (97.6%: 95% CI = 93-100%). Side effects could be attributed to each drug separately: fevers, rigors and back pain due to Ambisome; gastrointestinal side effects due to miltefosine. This combination is attractive for reasons of efficacy, tolerance, and feasibility of administration, although the gastrointestinal side effects of miltefosine require medical vigilance. Clinical Trials.gov identification number: NCT00371995.
AuthorsShyam Sundar, Prabhat Kumar Sinha, Deepak K Verma, Nawin Kumar, Shahnawaj Alam, Krishna Pandey, Poonam Kumari, Vidyanand Ravidas, Jaya Chakravarty, Neena Verma, Jonathan Berman, Hashim Ghalib, Byron Arana
JournalTransactions of the Royal Society of Tropical Medicine and Hygiene (Trans R Soc Trop Med Hyg) Vol. 105 Issue 2 Pg. 115-7 (Feb 2011) ISSN: 1878-3503 [Electronic] England
PMID21129762 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2010 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.
Chemical References
  • Antiprotozoal Agents
  • liposomal amphotericin B
  • Phosphorylcholine
  • miltefosine
  • Amphotericin B
Topics
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Amphotericin B (administration & dosage)
  • Antiprotozoal Agents (administration & dosage, adverse effects)
  • Child
  • Child, Preschool
  • Drug Therapy, Combination (methods)
  • Female
  • Gastrointestinal Diseases (chemically induced)
  • Humans
  • Infusions, Intravenous
  • Leishmaniasis, Visceral (complications, drug therapy)
  • Male
  • Middle Aged
  • Phosphorylcholine (administration & dosage, adverse effects, analogs & derivatives)
  • Treatment Outcome
  • Young Adult

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