NCT00497601 - A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions

Visceral Leishmaniasis

Interventions

DRUG

Amphotericin B fat emulsion in visceral leishmaniasis

Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 \& 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 \& 5 mg/kg on day 1 \& 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 \& 2.5 mg/kg on day 1 \& 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D

DRUG

Amphotericin B fat emulsion

Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1

DRUG

Amphotericin B in fat emulsion

Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1

Trial Locations (1)

842001

Kala-azar Medical Research Center, Muzaffarpur

All Listed Sponsors

lead

Banaras Hindu University

OTHER