Overview
Despite talaromycosis being one of the leading causes of AIDS-related mortality in Southeast Asia, current treatment options remain limited and problematic.
Deoxycholate Amphotericin B (DAmB), which is used for induction therapy, is highly toxic; whilst itraconazole, which is used for consolidation and maintenance therapy, is associated with poor oral bioavailability.
Safer and potentially more effective drugs for talaromycosis are available but have not been studied. Liposomal Amphotericin B (LAmB) is a safer formulation that has long replaced DAmB in high-income countries, while 5FC is routinely administered as an add-on treatment for cryptococcosis.
Study Design
The LAmB-FAST trial is a 2×2 factorial, randomized, open label controlled trial testing, on one factor, the single 10mg/kg LAmB vs 14 days of DAmB (AIM 1); and on a second factor, with or without 5FC in addition to DAmB or LAmB for the induction therapy of talaromycosis (AIM 2).
This will be followed by the STOP-SHORT sub-study which is a follow-on nested randomized controlled trial testing the effectiveness of a viral load guided strategy for itraconzole cessation versus the established CD4-count guided strategy in the prevention of disease relapse (AIM 3).
The trial will be coordinated by the existing partnership between the Duke School of Medicine and the TMRC for Talaromycosis at Pham Ngoc Thach University of Medicine in Ho Chi Minh City, Vietnam; and take place across four study sites throughout Vietnam and 4 study sites in Thailand:
The trial is predicted to commence in mid-to-late 2026.