Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
LAmB-FAST
1 other identifier
interventional
428
2 countries
5
Brief 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2026
Longer than P75 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
Study Completion
Last participant's last visit for all outcomes
July 1, 2031
April 23, 2026
April 1, 2026
4 years
July 24, 2024
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from enrollment to a composite of poor outcomes
Poor outcomes are defined as of death, talaromycosis complications (defined as relapse, immune inflammatory reconstitution inflammatory syndrome \[IRIS\], wasting syndrome \[\>10% weight loss from enrollment\], re-hospitalization, and grade 3 or higher adverse events
up to 24 weeks
Secondary Outcomes (5)
All cause mortality
up to 24 weeks
Fungal clearance rate as measured by early fungicidal activity (EFA) in log10 CFUs/mL/day
14 days
Composite ordinal desirability of outcome ranking (DOOR) scale
over 24 weeks
Change in Talaromyces marneffei DNA in copies/mL/week
baseline to 24 weeks
Change in Talaromyces marneffei antigen in µg/mL/week
baseline to 24 weeks
Study Arms (4)
Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC) placebo
ACTIVE COMPARATORDAmB (0.7mg/kg/d IV x 14 days) + 5FC placebo (25 mg/kg oral 3x daily x 14 days)
Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC)
EXPERIMENTALDAmB (0.7 mg/kg/d IV x 14 days) + 5FC (25 mg/kg oral 3x daily x 14 days)
Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC) placebo
EXPERIMENTALLAmB (10 mg/kg IV x 1 dose) + 5FC placebo (25 mg/kg oral 3x daily x 14 days)
Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC)
EXPERIMENTALLAmB (10 mg/kg IV x 1 dose) + 5FC (25 mg/kg oral 3x daily x 14 days)
Interventions
Antifungal dosed at 25mg/kg oral 3x daily.
Similar in appearance to flucytosine. Also dosed at 25mg/kg oral 3x daily.
Antifungal dosed at 10 mg/kg/day IV x one single dose.
Antifungal dosed at 0.7 mg/kg/day IV x 2 weeks.
Eligibility Criteria
You may qualify if:
- HIV infected adults (age greater or equal to 18), on ART or no ART
- Definitive talaromycosis confirmed by microscopy, histology, or culture
You may not qualify if:
- Known severe allergy to AmB or 5FC
- Absolute neutrophil count \<500 cells
- Concurrent cryptococcal or TB meningitis
- Received \> 2 doses of DAmB
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bach Mai Hospitalcollaborator
- Gilead Sciencescollaborator
- Viatris Inc.collaborator
- Duke Universitylead
- Pham Ngoc Thach University of Medicinecollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnamcollaborator
- National Hospital for Tropical Diseases, Hanoi, Vietnamcollaborator
Study Sites (5)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Bach Mai Hospital
Hanoi, Vietnam
National Hospital for Tropical Diseases
Hanoi, Vietnam
Hospital for Tropical Diseases
Ho Chi Minh City, 7000, Vietnam
Pham Ngoc Thach University of Medicine
Ho Chi Minh City, 7000, Vietnam
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thuy Le, MD, PhD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Liposomal amphotericin B vs deoxycholate amphotericin B arm is an open label comparison Flucytosine vs no flucytosine is a placebo controlled comparison
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2024
First Posted
July 29, 2024
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
July 1, 2031
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will become available when all primary and secondary analyses are completed and published and will be available in the Duke Research Data Repository (RDR) indefinitely
- Access Criteria
- Contact PI
Data sharing with the scientific community will be carried out according to the FAIR Guiding Principles and spirit of open-access. Previously published data sets will be made available to the scientific community upon request after agreement by the Trial Steering Commitee. The Duke Data Manager will deposit the de-identified master data file into the Duke Research Data Repository (RDR), an openly accessible preservation archive maintained by the Duke University Libraries.