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Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Sponsor: Federal University of Health Science of Porto Alegre
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
Conditions
Interventions
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
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