Clinical Trial: Combination Chemotherapy for the Treatment of Indian Kala-Azar

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

Official Title: Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study

Brief Summary: The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.

Detailed Summary: In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm.
Sponsor: Banaras Hindu University

Current Primary Outcome: Absence of clinical kala-azar at six month follow up

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Banaras Hindu University

Dates:
Date Received: August 31, 2006
Date Started: September 2006
Date Completion:
Last Updated: September 11, 2008
Last Verified: September 2008