Amphotericin B Lipid Complex Versus Meglumine Antimoniate in the Treatment of Visceral Leishmaniasis in Patients Infected With HIV: A Randomized Pilot Study

J Antimicrob Chemother. 2003 Sep;52(3):464-8. doi: 10.1093/jac/dkg356. Epub 2003 Jul 29.

Abstract

Optimal treatment for HIV-related visceral leishmaniasis (VL) has still to be established. A pilot clinical trial was carried out in 57 HIV-VL coinfected patients to compare the efficacy and safety of amphotericin B lipid complex (ABLC) versus meglumine antimoniate. The patients were randomized to receive either ABLC 3 mg/kg/day for 5 days (ABLC-5, 18 patients), ABLC 3 mg/kg/day for 10 days (ABLC-10, 20 patients) or meglumine antimoniate 20 mg Sbv /kg/day for 28 days (19 patients). Treatment was considered successful if parasites were not detected in a bone marrow aspirate after treatment. Parasitological cure was attained in 33% (95% CI: 13%-59%) of the ABLC-5 group, in 42% (95% CI: 16%-62%) of the ABLC-10 group and in 37% (95% CI: 16%-62%) of the meglumine antimoniate group (P = 0.94). Eight out of 19 patients administered antimoniate discontinued treatment prematurely following serious adverse events, compared with one in the ABLC groups (P = 0.0006). The efficacy of ABLC is similar to meglumine antimoniate, but the severity of toxicity in the treatment of HIV-VL is lower with ABLC.

Publication types

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

MeSH terms

  • Adult
  • Amphotericin B / administration & dosage
  • Amphotericin B / adverse effects
  • Amphotericin B / therapeutic use*
  • Antiprotozoal Agents / administration & dosage
  • Antiprotozoal Agents / adverse effects
  • Antiprotozoal Agents / therapeutic use*
  • Bone Marrow / parasitology
  • Double-Blind Method
  • Drug Combinations
  • Female
  • HIV Infections / complications*
  • Humans
  • Leishmaniasis, Visceral / complications
  • Leishmaniasis, Visceral / drug therapy*
  • Leishmaniasis, Visceral / parasitology
  • Male
  • Meglumine / adverse effects
  • Meglumine / therapeutic use*
  • Meglumine Antimoniate
  • Organometallic Compounds / adverse effects
  • Organometallic Compounds / therapeutic use*
  • Phosphatidylcholines / administration & dosage
  • Phosphatidylcholines / adverse effects
  • Phosphatidylcholines / therapeutic use*
  • Phosphatidylglycerols / administration & dosage
  • Phosphatidylglycerols / adverse effects
  • Phosphatidylglycerols / therapeutic use*
  • Pilot Projects
  • Treatment Outcome

Substances

  • Antiprotozoal Agents
  • Drug Combinations
  • Organometallic Compounds
  • Phosphatidylcholines
  • Phosphatidylglycerols
  • liposomal amphotericin B
  • Meglumine
  • Meglumine Antimoniate
  • Amphotericin B