Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh

Phase 3 Completed 602 enrolled Drugs for Neglected Diseases International Centre for Diarrhoeal Disease Research, Bangladesh · collab Shaheed Suhrawardy Medical College and Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This protocol will evaluate the efficacy and safety of various combinations of the three drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard treatment with a total dose of 15mg/kg of AmBisome.

Timeline

Start: 2010-05
Primary completion: 2014-03
Completion: 2014-03

Outcome

Met primary endpoint

paper CONCLUSION: None of the combinations were inferior to AmBisome in both the intention-to-treat and per-protocol populations. PMID 28558062 ↗

release “The combination treatments (AmBisome® + miltefosine; AmBisome® + paromomycin; paromomycin + miltefosine) were non-inferior to AmBisome® monotherapy” dndi.org ↗

Publications

Rahman R, Goyal V, Haque R, Jamil K, Faiz A, Samad R, Ellis S, Balasegaram M, Boer MD, Rijal S, Strub-Wourgaft N, Alves F, Alvar J, Sharma B. Safety and efficacy of short course combination regimens with AmBisome, miltefosine and paromomycin for the treatment of visceral leishmaniasis (VL) in Bangladesh. PLoS Negl Trop Dis. 2017 May 30;11(5):e0005635. doi: 10.1371/journal.pntd.0005635. eCollection 2017 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amphotericin B	Unknown	5 mg/kg	Intravenous
Subject	Miltefosine	Small molecule	1.5 mg/kg	Oral
Subject	Miltefosine	Small molecule	2.5 mg/kg	Oral
Subject	Paromomycin	Small molecule	11 mg/kg	Intramuscular