Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Talaromycosis

In brief

LAmB-FAST is a factorial randomized controlled trial simultaneously testing two interventions in one trial. LAmB-FAST seeks to inform treatment guidelines on the induction and maintenance therapy of HIV-associated talaromycosis (formerly called penicilliosis) and will answer the following three questions: 1. Is induction therapy using a single 10 mg\\/kg dose of liposomal amphotericin B (LAmB) is more effective than 14 days of the conventional deoxycholate amphotericin B (DAmB)? 2. Is adding flucytosine (5FC) to amphotericin B more effective than amphotericin B alone? 3. Is HIV viral load guided stopping of itraconazole maintenance therapy as effective as the current CD4 guided strategy in the prevention of talaromycosis relapse?

Key facts

Study ID

NCT06525389

Run by

Duke University

People needed

428

Starts

2026-07-01

Expected to finish

2031-07-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infected adults (age greater or equal to 18), on ART or no ART
• Definitive talaromycosis confirmed by microscopy, histology, or culture

You may not qualify if…

• Known severe allergy to AmB or 5FC
• Absolute neutrophil count <500 cells
• Concurrent cryptococcal or TB meningitis
• Received > 2 doses of DAmB
• Pregnancy

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• Bach Mai Hospital — Hanoi, Vietnam
• National Hospital for Tropical Diseases — Hanoi, Vietnam
• Hospital for Tropical Diseases — Ho Chi Minh City, Vietnam
• Pham Ngoc Thach University of Medicine — Ho Chi Minh City, Vietnam

Full record on ClinicalTrials.gov

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