Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)

Conditions

• Talaromycosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Liposomal Amphotericin B (LAmB) — DRUG
  Antifungal dosed at 10 mg/kg/day IV x one single dose.
• Flucytosine (5FC) — DRUG
  Antifungal dosed at 25mg/kg oral 3x daily.
• Flucytosine (5FC) placebo pill — DRUG
  Similar in appearance to flucytosine. Also dosed at 25mg/kg oral 3x daily.
• Deoxycholate Amphotericin B (DAmB) — DRUG
  Antifungal dosed at 0.7 mg/kg/day IV x 2 weeks.

Study Details

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?

Key Dates

Start date

Jul 1, 2026

Status verified

Apr 2026

Primary completion

Jul 1, 2030

Completion

Jul 1, 2031

Study Design

Enrollment

428 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC) placebo
  DAmB (0.7mg/kg/d IV x 14 days) + 5FC placebo (25 mg/kg oral 3x daily x 14 days)
• Experimental: Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC)
  DAmB (0.7 mg/kg/d IV x 14 days) + 5FC (25 mg/kg oral 3x daily x 14 days)
• Experimental: Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC) placebo
  LAmB (10 mg/kg IV x 1 dose) + 5FC placebo (25 mg/kg oral 3x daily x 14 days)
• Experimental: Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC)
  LAmB (10 mg/kg IV x 1 dose) + 5FC (25 mg/kg oral 3x daily x 14 days)

Primary Outcome Measure

Time from enrollment to a composite of poor outcomes [ Time Frame: up to 24 weeks ]

Central Contacts

• Thuy Le, MD, PhD
  919-668-5053
  [email protected]

Locations (1)

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