NCT01310738

Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil

Multicentric Efficacy and Safety Study of Antileishmanial Drugs for Treatment of Visceral Leishmaniasis in Brazil

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 6 Months – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Visceral Leishmaniasis

Interventions

Type	Name	Description
DRUG	Antimoniate of N-methylglucamine	Antimoniate of N-methyl glucamine 20mg/kg/d of pentavalent antimonial, I.V. for 20 consecutive days.
DRUG	amphotericin B deoxycholate	1mg/kg/d, I.V. for 14 consecutive days.
DRUG	Liposomal amphotericin B	3mg/kg/d, I.V. for 7 consecutive days.
DRUG	Liposomal amphotericin B	10mg/kg/d, I.V. single dose.
DRUG	Antimoniate of N-methylglucamine	20mg/kg/d of pentavalent antimonial I.V. for 10 days

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-10-01
• Completion: 2015-02-01
• First posted: 2011-03-08
• Last updated: 2017-09-05

Locations

5 sites across 1 country: Brazil