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Anti-fungal
Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC) for Fungal Infection (LAmB-FAST Trial)
Phase 3
Waitlist Available
Led By Thuy Le, MD, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* HIV infected adults (age greater or equal to 18), on ART or no ART
* Definitive talaromycosis confirmed by microscopy, histology, or culture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 24 weeks
Awards & highlights
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?
Who is the study for?
This trial is for individuals with HIV-associated talaromycosis, a fungal infection. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided here.
What is being tested?
The LAmB-FAST trial is testing whether a single dose of Liposomal Amphotericin B (LAmB) is more effective than the standard 14-day treatment with Deoxycholate Amphotericin B (DAmB), and if adding Flucytosine (5FC) improves outcomes. It also examines different strategies for stopping maintenance therapy to prevent relapse.
What are the potential side effects?
Potential side effects may include kidney problems, electrolyte imbalances, fever or chills related to infusion reactions from amphotericin B treatments; nausea or low blood counts from flucytosine could occur as well.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time from enrollment to a composite of poor outcomes
Secondary study objectives
All cause mortality
Change in Talaromyces marneffei DNA in copies/mL/week
Change in Talaromyces marneffei antigen in µg/mL/week
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC) placeboExperimental Treatment2 Interventions
LAmB (10 mg/kg IV x 1 dose) + 5FC placebo (25 mg/kg oral 3x daily x 14 days)
Group II: Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC)Experimental Treatment2 Interventions
LAmB (10 mg/kg IV x 1 dose) + 5FC (25 mg/kg oral 3x daily x 14 days)
Group III: Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC)Experimental Treatment2 Interventions
DAmB (0.7 mg/kg/d IV x 14 days) + 5FC (25 mg/kg oral 3x daily x 14 days)
Group IV: Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC) placeboActive Control2 Interventions
DAmB (0.7mg/kg/d IV x 14 days) + 5FC placebo (25 mg/kg oral 3x daily x 14 days)
Find a Location
Who is running the clinical trial?
Pham Ngoc Thach University of MedicineOTHER
4 Previous Clinical Trials
2,235 Total Patients Enrolled
Maharat Nakhon Ratchasima HospitalOTHER
2 Previous Clinical Trials
3,340 Total Patients Enrolled
Chiang Mai UniversityOTHER
128 Previous Clinical Trials
35,261 Total Patients Enrolled
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