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

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?

Conditions

• Talaromycosis

Interventions

DRUG

Liposomal Amphotericin B (LAmB)

Antifungal dosed at 10 mg/kg/day IV x one single dose.

DRUG

Flucytosine (5FC)

Antifungal dosed at 25mg/kg oral 3x daily.

DRUG

Flucytosine (5FC) placebo pill

Similar in appearance to flucytosine. Also dosed at 25mg/kg oral 3x daily.

DRUG

Deoxycholate Amphotericin B (DAmB)

Antifungal dosed at 0.7 mg/kg/day IV x 2 weeks.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Pham Ngoc Thach University of Medicine

  collaborator OTHER

• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

  collaborator OTHER

• National Hospital for Tropical Diseases, Hanoi, Vietnam

  collaborator OTHER_GOV

• Bach Mai Hospital

  collaborator OTHER

• Gilead Sciences

  collaborator INDUSTRY

• Viatris Inc.

  collaborator INDUSTRY

• Duke University

  lead OTHER

Principal Investigators

• Thuy Le, MD, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2030-07-01

Completion

2031-07-01

FDA Drug

Yes

Countries

• United States
• Vietnam

Study Locations