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

Phase 3 Recruiting 279 enrolled Federal University of Health Science of Porto Alegre Financiadora de Estudos e Projetos · collab Gilead Sciences · collab Immuno-mycologics, Inc. (IMMY) · collab Sociedade Gaucha de Infectologia · collab

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2025-01-16
Primary completion: 2026-08-28
Completion: 2026-11-28

Outcome

Missed primary endpoint

paper Day 14 clinical response was 84% for single-dose L-AmB, 69% 2-dose L-AmB, and 74% for control arm (P = .69). PMID 37232940 ↗

Publications

Pasqualotto AC, Lana DD, Godoy CSM, Leitao TDMJS, Bay MB, Damasceno LS, Soares RBA, Kist R, Silva LR, Wiltgen D, Melo M, Guimaraes TF, Guimaraes MR, Vechi HT, de Mesquita JRL, Monteiro GRG, Adenis A, Bahr NC, Spec A, Boulware DR, Israelski D, Chiller T, Falci DR. Single High Dose of Liposomal Amphotericin B in Human Immunodeficiency Virus/AIDS-Related Disseminated Histoplasmosis: A Randomized Trial. Clin Infect Dis. 2023 Oct 13;77(8):1126-1132. doi: 10.1093/cid/ciad313.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amphotericin B	Unknown	3 mg/kg	—
Subject	Amphotericin B	Unknown	10 mg/kg	—