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

Author(s): Laguna F, Videla S, Jimenez-Mejias ME, Sirera G, Torre-Cisneros J, Ribera E, Prados D, Clotet B, Sust M, Lopez-Velez R, Alvar J, Spanish HIV-Leishmania Study Group

Affiliation(s): Servicio de Enfermedades Infecciosas, Hospital Carlos III, Instituto de Salud Carlos III, C/Sinesio Delgado 12, 28029-Madrid, Spain. flaguna@hotmail.com

Publication date & source: 2003-09, J Antimicrob Chemother., 52(3):464-8. Epub 2003 Jul 29.

Publication type: Clinical Trial; Randomized Controlled Trial

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.

Page last updated: 2006-01-31

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