Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil
Status:
Terminated
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Brasilia
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico Drugs for Neglected Diseases Ministry of Health, Brazil
Treatments:
Amphotericin B Amphotericin B, deoxycholate drug combination Deoxycholic Acid Liposomal amphotericin B Meglumine Antimoniate