Clinical Trial

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

Recruiting Phase 3
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).
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-08-28 -> 2032-07-01 2026-07-28
minor Completion pushed: 2026-11-28 -> 2032-07-01 2026-07-28
Trial Details
NCT Number NCT05814432
Lead Sponsor Federal University of Health Science of Porto Alegre
Collaborators: Gilead Sciences, Financiadora de Estudos e Projetos, Sociedade Gaucha de Infectologia, Immuno-mycologics, Inc. (IMMY)
Conditions Disseminated Histoplasma Capsulatum Infection, AIDS and Infections, Immunosuppression, Fungal Infection
Enrollment 279 participants
Start Date 2025-01-16
Primary Completion 2032-07-01 (estimated)
Study Completion 2032-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-27