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).

NCT00497601 Phase 2 COMPLETED

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.

Details

Lead sponsor	Banaras Hindu University
Phase	Phase 2
Status	COMPLETED
Enrolment	60
Start date	2007-02
Completion	2008-07

Conditions

• Visceral Leishmaniasis

Interventions

• Amphotericin B fat emulsion in visceral leishmaniasis
• Amphotericin B fat emulsion
• Amphotericin B in fat emulsion

Primary outcomes

• Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months, no hematological, hepatic or renal toxicity — one year

Countries

India