Combination Chemotherapy for the Treatment of Indian Kala-Azar
The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.
Drug: Combination therapy with AmBisome and miltefosine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study|
- Absence of clinical kala-azar at six month follow up
|Study Start Date:||September 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370825
|Kala-azar Medical Research Center|
|Muzaffarpur, Bihar, India, 842001|
|Principal Investigator:||Shyam Sundar, MD||Banaras Hindu University|