Combination Therapy in Indian Visceral Leishmaniasis

PHASE3CompletedINTERVENTIONAL
Enrollment

624

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

August 31, 2009

Study Completion Date

February 28, 2010

Conditions
Leishmaniasis, Visceral
Interventions
DRUG

amphotericin B deoxycholate

Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions

DRUG

Liposomal Amphotericin B with Miltefosine

Liposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or \> 25 kg Miltefosine 50 mg once daily if patient weighs \<25 mg

DRUG

Liposomal Amphotericin B and Paromomycin Sulfate

AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11

DRUG

miltefosine + Paromomycin sulfate

oral miltefosine 50mg once daily (\< 25 kg body weight) or twice daily ( \> 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days

Trial Locations (1)

842001

Kala-azar Medical Research Center, Muzaffarpur

All Listed Sponsors
collaborator

Drugs for Neglected Diseases

OTHER

collaborator

Rajendra Memorial Research Institute of Medical Sciences

OTHER

lead

Banaras Hindu University

OTHER

NCT00523965 - Combination Therapy in Indian Visceral Leishmaniasis | Biotech Hunter | Biotech Hunter