Clinical Trial: Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.

Sponsor: Banaras Hindu University

Current Primary Outcome: Final cure rate at six months after the end of treatment [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Initial cure after the end of treatment [ Time Frame: six months ]

Original Secondary Outcome: Same as current

Information By: Banaras Hindu University

Dates:
Date Received: February 20, 2008
Date Started: February 2008
Date Completion:
Last Updated: April 2, 2009
Last Verified: April 2009