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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

428

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

July 1, 2030

Study Completion Date

July 1, 2031

Conditions
Talaromycosis
Interventions
DRUG

Liposomal Amphotericin B (LAmB)

Antifungal dosed at 10 mg/kg/day IV x one single dose.

DRUG

Flucytosine (5FC)

Antifungal dosed at 25mg/kg oral 3x daily.

DRUG

Flucytosine (5FC) placebo pill

Similar in appearance to flucytosine. Also dosed at 25mg/kg oral 3x daily.

DRUG

Deoxycholate Amphotericin B (DAmB)

Antifungal dosed at 0.7 mg/kg/day IV x 2 weeks.

Trial Locations (5)

7000

Hospital for Tropical Diseases, Ho Chi Minh City

Pham Ngoc Thach University of Medicine, Ho Chi Minh City

27710

Duke University Medical Center, Durham

Unknown

Bach Mai Hospital, Hanoi

National Hospital for Tropical Diseases, Hanoi

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Pham Ngoc Thach University of Medicine

OTHER

collaborator

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

OTHER

collaborator

National Hospital for Tropical Diseases, Hanoi, Vietnam

OTHER_GOV

collaborator

Bach Mai Hospital

OTHER

collaborator

Gilead Sciences

INDUSTRY

collaborator

Viatris Inc.

INDUSTRY

lead

Duke University

OTHER