A Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis.
Status:
Completed
Trial end date:
2007-09-14
Target enrollment:
Participant gender:
Summary
Sitamaquine is an 8-aminoquinoline which is being developed as an oral treatment for visceral
leishmaniasis (VL). Pre-clinical and subsequent clinical investigations have demonstrated
oral efficacy against Leishmania donovani. The purposes of this study are to characterise the
pharmacokinetic profile of sitamaquine, administered orally, and to determine if the
pharmacokinetic profile is affected by administration with food. The study is also designed
to further characterise the safety and tolerability of sitamaquine compared with amphotericin
B, particularly in reference to renal, hepatic and cardiac adverse events, prior to
initiation of phase III studies. Finally the study will investigate the efficacy of a 21 day
treatment course. Previous studies have used 28 days dosing, but parasitological evidence
from one study suggests that shorter courses may be effective.