Visceral Leishmaniasis Clinical Trial
Official title:
Multicentric Efficacy and Safety Study of Antileishmanial Drugs for Treatment of Visceral Leishmaniasis in Brazil
This study is aimed to compare the efficacy and safety of medications currently used in Brazil for treatment of visceral leishmaniasis. The investigators will compare the effects of meglumine antimoniate, two formulations of amphotericin B: deoxycholate and liposomal, and a combination of meglumine plus the liposomal amphotericin B formulation. The study is designed to demonstrate the difference in efficacy measured as cure rate at six months after treatment and the safety profile based on the adverse event rate observed with each intervention.
Visceral leishmaniasis is a relevant public health problem in Brazil with approximately 3500
cases registered every year. Eight percent lethality rate has been observed during the past
decade in spite of free of charge availability of antileishmanial drugs supplied by the
public health system.
The present study was designed as a phase IV, multicentric, open label, active controlled
clinical trial targeted to visceral leishmaniasis adult and pediatric cases.
The current drugs approved for visceral leishmaniasis treatment in Brazil will be compared in
four treatment groups: meglumine antimoniate, amphotericin B deoxycholate, liposomal
amphotericin B and a combination of single dose of liposomal amphotericin B plus meglumine
antimoniate. Meglumine antimoniate treated patients will constitute the active control group.
Drugs will be compared based on the cure rate observed after six months follow-up.
The study arm submitted to treatment with Amphotericin B deoxycholate was suspended in
September 2012.
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