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.
Publication types
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Clinical Trial
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Comparative Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Amphotericin B / administration & dosage
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Amphotericin B / adverse effects
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Amphotericin B / therapeutic use*
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Antiprotozoal Agents / administration & dosage
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Antiprotozoal Agents / adverse effects
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Antiprotozoal Agents / therapeutic use*
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Bone Marrow / parasitology
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Double-Blind Method
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Drug Combinations
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Female
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HIV Infections / complications*
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Humans
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Leishmaniasis, Visceral / complications
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Leishmaniasis, Visceral / drug therapy*
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Leishmaniasis, Visceral / parasitology
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Male
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Meglumine / adverse effects
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Meglumine / therapeutic use*
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Meglumine Antimoniate
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Organometallic Compounds / adverse effects
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Organometallic Compounds / therapeutic use*
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Phosphatidylcholines / administration & dosage
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Phosphatidylcholines / adverse effects
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Phosphatidylcholines / therapeutic use*
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Phosphatidylglycerols / administration & dosage
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Phosphatidylglycerols / adverse effects
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Phosphatidylglycerols / therapeutic use*
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Pilot Projects
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Treatment Outcome
Substances
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Antiprotozoal Agents
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Drug Combinations
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Organometallic Compounds
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Phosphatidylcholines
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Phosphatidylglycerols
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liposomal amphotericin B
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Meglumine
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Meglumine Antimoniate
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Amphotericin B