NCT00497601

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

A Prospective, Single Center, Open-Label, Dose-Escalation Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Treatment Naïve Or Resistant Cases Of Visceral Leishmaniasis (Kala-Azar).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Banaras Hindu University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is: 1. To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations. 2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar.

Detailed description

1. To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations. 2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar. Subjects will be administered the study drug in either of the following four dose levels in an ascending manner, starting with the first dosage regimen: * 7.5 mg/kg on day 1 and day3 (Regimen 1) * 10 mg/kg on day 1, followed by 5 mg/kg on day 3 (Regimen 2) * 12.5 mg/kg on day 1, followed by 2.5 mg/kg on day 3 (Regimen 3) * Single-bolus infusion of 15 mg/kg over 2-4 hours on day 1 (Regimen 4)

Conditions

• Visceral Leishmaniasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-07-06
• Last updated: 2008-09-12

Locations

1 site across 1 country: India