1. Amphotericin B lipid complex versus meglumine antimoniate in the treatment of visceral leishmaniasis in patients infected with HIV: a randomized pilot study.
- Author
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Laguna F, Videla S, Jiménez-Mejías ME, Sirera G, Torre-Cisneros J, Ribera E, Prados D, Clotet B, Sust M, López-Vélez R, and Alvar J
- Subjects
- Adult, Amphotericin B administration & dosage, Amphotericin B adverse effects, Antiprotozoal Agents administration & dosage, Antiprotozoal Agents adverse effects, Bone Marrow parasitology, Double-Blind Method, Drug Combinations, Female, Humans, Leishmaniasis, Visceral complications, Leishmaniasis, Visceral parasitology, Male, Meglumine adverse effects, Meglumine Antimoniate, Organometallic Compounds adverse effects, Phosphatidylcholines administration & dosage, Phosphatidylcholines adverse effects, Phosphatidylglycerols administration & dosage, Phosphatidylglycerols adverse effects, Pilot Projects, Treatment Outcome, Amphotericin B therapeutic use, Antiprotozoal Agents therapeutic use, HIV Infections complications, Leishmaniasis, Visceral drug therapy, Meglumine therapeutic use, Organometallic Compounds therapeutic use, Phosphatidylcholines therapeutic use, Phosphatidylglycerols therapeutic use
- 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.
- Published
- 2003
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