Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
NCT Number: NCT06525389
Acronym: LAmB-FAST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Talaromycosis
Interventions: DRUG: Liposomal Amphotericin B (LAmB)|DRUG: Flucytosine (5FC)|DRUG: Flucytosine (5FC) placebo pill|DRUG: Deoxycholate Amphotericin B (DAmB)
Sponsor: Duke University
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)|Pham Ngoc Thach University of Medicine|Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam|National Hospital for Tropical Diseases, Hanoi, Vietnam|Bach Mai Hospital|Siriraj Hospital, Mahidol University, Bangkok, Thailand.|Maharat Nakhon Ratchasima Hospital|Chiang Mai University|Guangzhou 8th People's Hospital|Shenzhen Third People's Hospital|Gilead Sciences|Viatris Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 428
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-06
Completion Date: 2032-01-06
Locations: Duke University Medical Center, Durham, North Carolina, 27710, United States|Quangzhou 8th People Hospital, Guangzhou, China|Fourth People's Hospital of Nanning, Nanning, China|Shenzhen 3rd Hospital, Shenzhen, China|Siriraj Hospital, Bangkok, Thailand|Chiang Mai University Hospital, Chiang Mai, Thailand|Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, Thailand|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

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?

Primary Outcome Measures: 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 Outcome Measures: 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, All-cause mortality, Talaromycosis complications and adverse events grade 4, Adverse events grade 3, and Quality of Life (QOL) utility scores by EQ5D 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