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

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.

Conditions

• Visceral Leishmaniasis

Interventions

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

Sponsors & Collaborators

• Ministry of Health, Brazil

  collaborator OTHER_GOV

• Drugs for Neglected Diseases

  collaborator OTHER

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• University of Brasilia

  lead OTHER

Principal Investigators

• Carlos HN Costa, MD PhD · Federal University of Piaui

• Dorcas L Costa, MD PhD · Federal University of Piaui

• Ana LT Rabello, MD PhD · Centro de Pesquisas Rene Rachou - Fiocruz - Minas Gerais

• Silvio FG de Carvalho, MD PhD · Montes Claros State University - Unimontes

• Andrea L de Carvalho, MD · Hospital Infantil Joao Paulo II - FHEMIG

• Roque P de Almeida, MD PhD · Federal University of Sergipe

• Fabiana P Alves, MD PhD · Drugs for Neglected Diseases

• Gustavo AS Romero, MD PhD · University of Brasilia

• Robério D Leite, MD, PhD · Hospital São José de Doenças Infecciosas, Secretaria de Saúde do Estado do Ceará.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2014-10-31

Completion

2015-02-28

Countries

• Brazil

Study Locations