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JAC Advance Access published online on July 29, 2003
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkg356
© 2003 by The British Society for Antimicrobial Chemotherapy
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© 2003 The British Society for Antimicrobial Chemotherapy

Original article

Amphotericin B lipid complex versus meglumine antimoniate in the treatment of visceral leishmaniasis in patients infected with HIV: a randomized pilot study

Fernando Laguna 1 *, Sebastián Videla 2 , Manuel E. Jiménez-Mejías 3 , Guillem Sirera 4 , Julián Torre-Cisneros 5 , Esteban Ribera 6 , Dolores Prados 3 , Bonaventura Clotet 4 , Mariano Sust 2 , Rogelio López-Vélez 7 , Jorge Alvar 8 , and the Spanish HIV-Leishmania Study Group

1 Servicio de Enfermedades Infecciosas, Hospital Carlos III, Instituto de Salud Carlos III, C/Sinesio Delgado 12, 28029-Madrid
2 Laboratorios Dr Esteve, Barcelona
3 Hospital Virgen del Rocío, Sevilla
4 Hospital Germans Trias i Pujol, Badalona
5 Hospital Reina Sofía, Córdoba
6 Hospital Vall d'Hebron, Barcelona
7 Hospital Ramón y Cajal, Madrid
8 Centro Nacional de Microbiología, Majadahonda, Spain

* Corresponding author. E-mail: flaguna{at}hotmail.com.

Received 12 September 2002 ; revised 9 April 2003 ; accepted 4 June 2003

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.

Keywords: clinical trials, Leishmania, anti-leishmanial drugs
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