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Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
Sponsor: Duke University
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
428
Start Date
2026-05-01
Completion Date
2031-11-01
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Liposomal Amphotericin B (LAmB)
Antifungal dosed at 10 mg/kg/day IV x one single dose.
Flucytosine (5FC)
Antifungal dosed at 25mg/kg oral 3x daily.
Flucytosine (5FC) placebo pill
Similar in appearance to flucytosine. Also dosed at 25mg/kg oral 3x daily.
Deoxycholate Amphotericin B (DAmB)
Antifungal dosed at 0.7 mg/kg/day IV x 2 weeks.
Locations (5)
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