Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar

NCT00371995 ↗

Phase 2 Completed 150 enrolled Banaras Hindu University Rajendra Memorial Research Institute of Medical Sciences · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.

Timeline

Start: 2007-10
Primary completion: 2009-08
Completion: 2010-02

Publications

Results Sundar S, Sinha PK, Verma DK, Kumar N, Alam S, Pandey K, Kumari P, Ravidas V, Chakravarty J, Verma N, Berman J, Ghalib H, Arana B. Ambisome plus miltefosine for Indian patients with kala-azar. Trans R Soc Trop Med Hyg. 2011 Feb;105(2):115-7. doi: 10.1016/j.trstmh.2010.10.008. Epub 2010 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amphotericin B	Unknown	5 mg/kg	Intravenous
Subject	Miltefosine	Small molecule	50 mg	Oral
Subject	Miltefosine	Small molecule	100 mg	Oral

Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar

Summary

Timeline

Publications

Drugs

Indications