Who is sponsoring LVBrasil?

LVBrasil is sponsored by University of Brasilia.

What condition does LVBrasil study?

LVBrasil studies Visceral Leishmaniasis.

What drugs are being tested in LVBrasil?

Interventions: Antimoniate of N-methylglucamine, amphotericin B deoxycholate, Liposomal amphotericin B, Liposomal amphotericin B, Antimoniate of N-methylglucamine.

What is the status of LVBrasil?

LVBrasil is currently TERMINATED.

Last reviewed 2017-08-31 · How we verify

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

NCT01310738 Phase 4 TERMINATED

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.

Details

Lead sponsor	University of Brasilia
Phase	Phase 4
Status	TERMINATED
Enrolment	378
Start date	2011-02
Completion	2015-02

Conditions

Visceral Leishmaniasis

Interventions

Antimoniate of N-methylglucamine
amphotericin B deoxycholate
Liposomal amphotericin B
Liposomal amphotericin B
Antimoniate of N-methylglucamine

Primary outcomes

Cure rate — 6 month
Complete remission of clinical signs and symptoms, three months after treatment plus normal hematological lab evaluation and no relapse at sixth month follow-up.

Countries

Brazil