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Search / Trial NCT06525389

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

Launched by DUKE UNIVERSITY · Jul 24, 2024

Trial Information

Current as of November 13, 2025

Not yet recruiting

Keywords

Penicilliosis Talaromyces Marneffei Infection Penicillium Marneffei Infection

ClinConnect Summary

The LAmB-FAST trial is a research study that aims to find better ways to treat a fungal infection called talaromycosis, particularly in people living with HIV. This study will test two main ideas: first, whether a single dose of a medication called liposomal amphotericin B (LAmB) is more effective than a longer treatment with a different version of the same drug. Second, it will explore if adding another medication called flucytosine (5FC) improves the treatment outcomes compared to using LAmB alone. Additionally, the study will look into whether stopping a maintenance medication based on HIV viral load is as effective as the current method that relies on a specific immune cell count.

To participate in this trial, you need to be an adult (18 years or older) who is living with HIV and has been diagnosed with talaromycosis. However, certain conditions may prevent you from joining, such as having a severe allergy to the study medications, a low white blood cell count, or being pregnant. If you qualify, you can expect to receive either one of the treatment options and will be monitored closely throughout the study to see how well the treatments work. This trial is not yet recruiting participants, but it aims to improve future treatment guidelines for this serious condition.

Gender

ALL

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 \<500 cells
  • Concurrent cryptococcal or TB meningitis
  • Received \> 2 doses of DAmB
  • Pregnancy

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Bangkok, Thailand

Nakhon Ratchasima, Thailand

Hanoi, Vietnam

Hanoi, Vietnam

Ho Chi Minh City, Vietnam

Chiang Mai, Thailand

Nanning, China

Guangzhou, China

Shenzhen, China

Ho Chi Minh City, Vietnam

Patients applied

0 patients applied

Trial Officials

Thuy Le, MD, PhD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported