Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01310738
Study type Interventional
Source University of Brasilia
Contact
Status Terminated
Phase Phase 4
Start date February 2011
Completion date February 2015

See also
  Status Clinical Trial Phase
Terminated NCT02839603 - Asymptomatic Leishmania Infection in HIV Patients
Completed NCT00370825 - Combination Chemotherapy for the Treatment of Indian Kala-Azar Phase 2
Recruiting NCT05426577 - Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
Completed NCT01069198 - A Community Trial for Visceral Leishmaniasis (VL) N/A
Completed NCT00371995 - Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar Phase 2
Completed NCT00604955 - Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis Phase 4
Completed NCT01032187 - Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children Phase 4
Completed NCT00342823 - Immunogenetics of Visceral Leishmaniasis N/A
Completed NCT04003532 - LAMP Assay for the Diagnosis of Visceral Leishmaniasis
Terminated NCT01980199 - Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan Phase 2
Completed NCT00255567 - Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis Phase 3
Not yet recruiting NCT06118749 - Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study
Recruiting NCT04342715 - A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Completed NCT02431143 - Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa Phase 2
Completed NCT01122771 - Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh Phase 3
Completed NCT03636659 - Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition Phase 1
Not yet recruiting NCT01566552 - Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis Phase 4
Completed NCT00696969 - Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis Phase 3
Completed NCT00318721 - Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar N/A
Completed NCT00216346 - Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis Phase 3