title: Amphotericin B lipid complex versus meglumine antimoniate in the treatment of visceral leishmaniasis in patients infected with HIV: a randomized pilot study.
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.
authors.affiliation: Servicio de Enfermedades Infecciosas, Hospital Carlos III, Instituto de Salud Carlos III, C/Sinesio Delgado 12, 28029-Madrid, Spain. flaguna@hotmail.com
authors.forename: Fernando
authors.initials: F
authors.lastname: Laguna
authors.forename: Sebastián
authors.initials: S
authors.lastname: Videla
authors.forename: Manuel E
authors.initials: ME
authors.lastname: Jiménez-Mejías
authors.forename: Guillem
authors.initials: G
authors.lastname: Sirera
authors.forename: Julián
authors.initials: J
authors.lastname: Torre-Cisneros
authors.forename: Esteban
authors.initials: E
authors.lastname: Ribera
authors.forename: Dolores
authors.initials: D
authors.lastname: Prados
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.forename: Mariano
authors.initials: M
authors.lastname: Sust
authors.forename: Rogelio
authors.initials: R
authors.lastname: López-Vélez
authors.forename: Jorge
authors.initials: J
authors.lastname: Alvar
mesh_terms: D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000469:parasitology; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007898:Leishmaniasis, Visceral / Q000150:complications / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D008536:Meglumine / Q000009:adverse effects / Q000627:therapeutic use*; D000077485:Meglumine Antimoniate; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D010713:Phosphatidylcholines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010715:Phosphatidylglycerols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents; D004338:Drug Combinations; D009942:Organometallic Compounds; D010713:Phosphatidylcholines; D010715:Phosphatidylglycerols; C068538:liposomal amphotericin B; D008536:Meglumine; D000077485:Meglumine Antimoniate; D000666:Amphotericin B