Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Phase 3 Completed 400 enrolled Banaras Hindu University

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.

Timeline

Start: 2008-02
Primary completion: 2008-08
Completion: 2009-03

Outcome

Met primary endpoint

paper A single infusion of liposomal amphotericin B was not inferior to and was less expensive than conventional therapy with amphotericin B deoxycholate. PMID 20147716 ↗

Publications

Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med. 2010 Feb 11;362(6):504-12. doi: 10.1056/NEJMoa0903627.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amphotericin B	Unknown	10 mg/kg	Other
Comparator	amphotericin B deoxycholate	Unknown	1 mg/kg	Other