Visceral Leishmaniasis Clinical Trial
Official title:
A Prospective, Single Center, Open-Label, Dose-Escalation Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Treatment Naïve Or Resistant Cases Of Visceral Leishmaniasis (Kala-Azar).
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.
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.
Subjects will be administered the study drug in either of the following four dose levels in
an ascending manner, starting with the first dosage regimen:
- 7.5 mg/kg on day 1 and day3 (Regimen 1)
- 10 mg/kg on day 1, followed by 5 mg/kg on day 3 (Regimen 2)
- 12.5 mg/kg on day 1, followed by 2.5 mg/kg on day 3 (Regimen 3)
- Single-bolus infusion of 15 mg/kg over 2-4 hours on day 1 (Regimen 4)
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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