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NCT06525389
Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
Conditions: Talaromycosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 428
Sponsor: Duke University
Location: Duke University Medical Center Durham North Carolina
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?
Eligibility Criteria
Inclusion Criteria:
* HIV infected adults (age greater or equal to 18), on ART or no ART
* Definitive talaromycosis confirmed by microscopy, histology, or culture
Exclusion Criteria:
* Known severe allergy to AmB or 5FC
* Absolute neutrophil count \ 2 doses of DAmB
* Pregnancy
Source: ClinicalTrials.gov (NCT06525389). StuddyBuddy aggregates publicly available trial information.