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JAC Advance Access originally published online on July 29, 2003
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Journal of Antimicrobial Chemotherapy (2003) 52, 464-468
© 2003 The British Society for Antimicrobial Chemotherapy

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

Fernando Laguna1,*, Sebastián Videla2, Manuel E. Jiménez-Mejías3, Guillem Sirera4, Julián Torre-Cisneros5, Esteban Ribera6, Dolores Prados3, Bonaventura Clotet4, Mariano Sust2, Rogelio López-Vélez7 and Jorge Alvar8 on behalf of the Spanish HIV-Leishmania Study Group{dagger}

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

Received 12 September 2002; returned 7 March 2003; revised 9 April 2003; accepted 4 June 2003

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

* Corresponding author. Tel: +34-91-453-25-05; Fax: +34-91-733-66-14; E-mail: flaguna{at}hotmail.com

{dagger} Members are listed in the Acknowledgements


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