Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
Status:
NOT_YET_RECRUITING
Trial end date:
2031-07-01
Target enrollment:
Participant gender:
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?
Phase:
PHASE3
Details
Lead Sponsor:
Duke University
Collaborators:
Bach Mai Hospital Gilead Sciences Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam National Hospital for Tropical Diseases, Hanoi, Vietnam National Institute of Allergy and Infectious Diseases (NIAID) Pham Ngoc Thach University of Medicine Viatris Inc.
Treatments:
amphotericin B, deoxycholate drug combination Flucytosine liposomal amphotericin B