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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: Clinical Trial Phase 3 study, sponsored by Duke University.
NCT06525389 is a Phase 3 study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 428 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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?
Primary Outcome
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
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 |
What is known before NCT06525389 opens enrollment
NCT06525389 is an interventional study that assigns participants to a tested intervention. The registered 428 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 4 interventions - of which Liposomal Amphotericin B (LAmB) is the first listed.
NCT06525389 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06525389's enrollment target sits among peer trials
428 878th of 2000 higher than 1,121 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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