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NOT YET RECRUITING
NCT06525389
PHASE3

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

Sponsor: Duke University

View on ClinicalTrials.gov

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

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.

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