NCT00628719

Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With Visceral Leishmaniasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Banaras Hindu University · Academic / Other
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India. Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.

Conditions

• Visceral Leishmaniasis

Interventions

Type	Name	Description
DRUG	Liposomal Amphotericin B	a single dose of 10 mg/kg of liposomal amphotericin B
DRUG	amphotericin B deoxycholate	amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-08-01
• Completion: 2009-03-01
• First posted: 2008-03-05
• Last updated: 2009-04-03

Locations

1 site across 1 country: India