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Anti-fungal
Liposomal Amphotericin B + Flucytosine 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 antiretroviral therapy (ART) or not on ART
Definitive talaromycosis confirmed by microscopy, histology, or culture
Must not have
Concurrent cryptococcal or TB meningitis
Received more than 2 doses of DAmB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 24 weeks
Awards & highlights
Pivotal Trial
Summary
This trial, called LAmB-FAST, is testing two different treatments for HIV-associated talaromycosis. The trial will answer three questions: 1. Is using a single high dose
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 belowSelect...
I am an adult with HIV, with or without antiretroviral therapy.
Select...
My infection has been confirmed by lab tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have cryptococcal or TB meningitis.
Select...
I have received more than 2 doses of DAmB.
Timeline
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
Composite ordinal desirability of outcome ranking (DOOR) scale
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial 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
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2,235 Total Patients Enrolled
Maharat Nakhon Ratchasima HospitalOTHER
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Chiang Mai UniversityOTHER
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Bach Mai HospitalOTHER
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28,842 Total Patients Enrolled
Hospital for Tropical Diseases, Ho Chi Minh City, VietnamOTHER
22 Previous Clinical Trials
16,088 Total Patients Enrolled
Viatris Inc.Industry Sponsor
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4,998 Total Patients Enrolled
National Hospital for Tropical Diseases, Hanoi, VietnamOTHER_GOV
11 Previous Clinical Trials
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Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,119 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,137 Previous Clinical Trials
867,471 Total Patients Enrolled
Siriraj Hospital, Mahidol University, Bangkok, Thailand.UNKNOWN
2 Previous Clinical Trials
10,077 Total Patients Enrolled