Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
NCT ID: NCT06525389
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
428 participants
INTERVENTIONAL
2026-04-01
2031-11-01
Brief Summary
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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?
Detailed Description
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As a roadmap to identify safer and more effective antifungal strategies, LAmB-FAST applies major advances made in HIV-associated mycoses to accelerate treatment for HIV-associated talaromycosis. First, clinical trials in cryptococcosis showed that shorter courses (5 to 7 days) of DAmB was as effective and less toxic than the standard 14-day course of DAmB. The recent AMBITION cryptococcal meningitis showed that a single 10 mg/kg dose of liposomal amphotericin B (LAmB) was as effective as 7 to 14 days of DAmB but had 30% less toxicity, leading to rapid endorsement by the WHO as the first-line therapy for cryptococcal meningitis in 2022. A single LAmB induction therapy strategy has also been demonstrated in a phase II HIV-associated histoplasmosis trial which showed that a single 10 mg/kg dose of LAmB had similar mortality compared to 2 doses or 14 daily doses of LAmB. Second, the addition of flucytosine (5FC) to DAmB has been shown to improves fungal clearance in the cerebrospinnal fluid and survival of patients with cryptococcal meningitis. These advances in other HIV-associated mycoses lead us to hypothesize that 1) a single 10mg/kg dose of LAmB will be superior to 14 days of DAmB and 2) the addition of 5FC will be superior to DAmB or LAmB alone in the induction therapy of talaromyosis.
LAmB-FAST will test three related but independent specific aims: AIM 1: To determine if a single 10mg/kg dose of LAmB is superior to 14 days of DAmB in Tm complication-free survival. AIM 2:
To determine if combination therapy with 5FC is superior to DAmB or LAmB alone in Tm complication-free survival.
The primary outcome (for both AIM 1 and AIM 2) is hazard of a composite of death, Tm complications, and adverse events (AEs) grade 3 or higher.
The secondary outcomes include:
1. All-cause mortality;
2. Fungal clearance rate over first 14 days;
3. A novel 4-scale hierarchical outcome of i. Mortality, ii. Tm complications, iii. AEs grade 3, iv. Quality of life scores;
4. Rates of Tm DNA and Tm antigen decline over first 12 weeks.
AIM 3 will leverage access to a well-characterized and treated talaromycosis cohort in AIM 1 and AIM 2 to conduct a follow-on nested randomized controlled sub-study testing whether a HIV viral load guided strategy of stopping itraconazole chemoprophylaxis (STOP SHORT) is non-inferior to the current CD4 guided strategy in the prevention of talaromycosis relapse and death.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Flucytosine vs no flucytosine is a placebo controlled comparison
Study Groups
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Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC) placebo
DAmB (0.7mg/kg/d IV x 14 days) + 5FC placebo (25 mg/kg oral 3x daily x 14 days)
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.
Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC)
DAmB (0.7 mg/kg/d IV x 14 days) + 5FC (25 mg/kg oral 3x daily x 14 days)
Flucytosine (5FC)
Antifungal dosed at 25mg/kg oral 3x daily.
Deoxycholate Amphotericin B (DAmB)
Antifungal dosed at 0.7 mg/kg/day IV x 2 weeks.
Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC) placebo
LAmB (10 mg/kg IV x 1 dose) + 5FC placebo (25 mg/kg oral 3x daily x 14 days)
Flucytosine (5FC) placebo pill
Similar in appearance to flucytosine. Also dosed at 25mg/kg oral 3x daily.
Liposomal Amphotericin B (LAmB)
Antifungal dosed at 10 mg/kg/day IV x one single dose.
Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC)
LAmB (10 mg/kg IV x 1 dose) + 5FC (25 mg/kg oral 3x daily x 14 days)
Flucytosine (5FC)
Antifungal dosed at 25mg/kg oral 3x daily.
Liposomal Amphotericin B (LAmB)
Antifungal dosed at 10 mg/kg/day IV x one single dose.
Interventions
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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.
Liposomal Amphotericin B (LAmB)
Antifungal dosed at 10 mg/kg/day IV x one single dose.
Eligibility Criteria
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Inclusion Criteria
* Definitive talaromycosis confirmed by microscopy, histology, or culture
Exclusion Criteria
* Absolute neutrophil count \<500 cells
* Concurrent cryptococcal or TB meningitis
* Received \> 2 doses of DAmB
* Pregnancy
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Pham Ngoc Thach University of Medicine
OTHER
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
OTHER
National Hospital for Tropical Diseases, Hanoi, Vietnam
OTHER_GOV
Bach Mai Hospital
OTHER
Gilead Sciences
INDUSTRY
Viatris Inc.
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Thuy Le, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Thach N Pham, MD
Role: primary
Dung T Nguyen, MD
Role: primary
Other Identifiers
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Pro00113856
Identifier Type: -
Identifier Source: org_study_id