drugset / Trial / NCT00497601
A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2007-02
- Primary completion
- 2008-07
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amphotericin B | Unknown | 2.5 mg/kg | — |
| Subject | Amphotericin B | Unknown | 5 mg/kg | — |
| Subject | Amphotericin B | Unknown | 7.5 mg/kg | — |
| Subject | Amphotericin B | Unknown | 15 mg/kg | — |