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RECRUITING
NCT05814432
PHASE3

Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS

Sponsor: Federal University of Health Science of Porto Alegre

View on ClinicalTrials.gov

Summary

Phase III trial evaluating the safety and efficacy of a single high dose (10 mg/kg) of liposomal amphotericin B for disseminated histoplasmosis in AIDS patients, in comparison to standard therapy (3 mg/kg of liposomal amphotericin B for two weeks) (INDUCTION trial).

Official title: Efficacy and Safety of High-dose Liposomal Amphotericin B (10 Mg/kg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial (INDUCTION Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

279

Start Date

2025-01-16

Completion Date

2026-11-28

Last Updated

2025-02-04

Healthy Volunteers

No

Interventions

DRUG

Single high dose of liposomal amphotericin B

Single high dose (10 mg/kg) of liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS

DRUG

L-AmB standard dose

Standard treatment (3 mg/kg for two weeks) with liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS

Locations (5)

Hospital de Doenças Tropicais

Goiânia, Goiás, Brazil

Hospital Giselda Trigueiro

Natal, Rio Grande do Norte, Brazil

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Geral de Roraima

Boa Vista, Roraima, Brazil