drugset / Trial / NCT06525389
Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
Phase 3
Not yet recruiting
428 enrolled
Duke University
Bach Mai Hospital · collabGilead Sciences · collabHospital for Tropical Diseases, Ho Chi Minh City, Vietnam · collabNational Hospital for Tropical Diseases, Hanoi, Vietnam · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabPham Ngoc Thach University of Medicine · collabViatris Inc. · collab
RandomizedFactorialQuadruple-blindTreatment
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?
Timeline
- Start
- 2026-07-01
- Primary completion
- 2030-07-01
- Completion
- 2031-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amphotericin B | Unknown | 10 mg/kg | Intravenous |
| Subject | Deoxycholate Amphotericin B | Unknown | 0.7 mg/kg | Intravenous |
| Subject | Flucytosine | Small molecule | 25 mg/kg | Oral |