NCT00370825

Combination Chemotherapy for the Treatment of Indian Kala-Azar

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Banaras Hindu University · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: —

Summary

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

Detailed description

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.

Conditions

• Visceral Leishmaniasis

Interventions

Type	Name	Description
DRUG	Combination therapy with AmBisome and miltefosine

Timeline

• Start date: 2006-09-01
• First posted: 2006-09-01
• Last updated: 2008-09-12

Locations

1 site across 1 country: India