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NCT06525389 · ClinicalTrials.gov registry record · Phase 3
Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
A Phase 3 study, sponsored by Duke University.
- Not yet
- Registry status
- Phase 3
- Development phase
- 428
- Enrollment target
NCT06525389 is a Phase 3 study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 428 participants.
The verdict
NCT06525389, a Phase 3 study, has not yet begun recruiting, sponsored by Duke University.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 428 participants
- Enrollment target
Study 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?
Interventions
- DRUG Liposomal Amphotericin B (LAmB)
- DRUG Flucytosine (5FC)
- DRUG Flucytosine (5FC) placebo pill
- DRUG Deoxycholate Amphotericin B (DAmB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2031-07-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06525389
The ClinicalTrials.gov registry entry for NCT06525389 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 428 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Liposomal Amphotericin B (LAmB) is the first listed.
NCT06525389 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06525389 about?
NCT06525389 is a clinical study titled "Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)". 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 ques...
What is the current status of trial NCT06525389?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 428 participants. The study started on 2026-07-01. Estimated completion is 2031-07-01.
What interventions are being tested in trial NCT06525389?
The interventions under investigation include: Liposomal Amphotericin B (LAmB) (DRUG), Flucytosine (5FC) (DRUG), Flucytosine (5FC) placebo pill (DRUG), Deoxycholate Amphotericin B (DAmB) (DRUG).
Who is sponsoring clinical trial NCT06525389?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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