# Making an early diagnosis of talaromycosis - an approach to reduce morbidity and mortality in advanced HIV disease in Southeast Asia

> **NIH NIH R01** · DUKE UNIVERSITY · 2021 · $594,989

## Abstract

Talaromyces marneffei (Tm) is one of seven dimorphic human fungal pathogens that cause substantial
global morbidity and mortality in immunocompetent and immunocompromised individuals. Tm is
endemic throughout Southeast Asia where it is a leading cause of death with an on-treatment mortality
of 30% in people with advanced HIV disease. A critical barrier to reducing mortality is our inability to
make an early diagnosis. The disease is insidious, and early symptoms are non-specific. Diagnosis
relies on culturing the organism from clinical specimens which is only positive during advanced stage
of disease and takes up to 14 days to identify. Consequently many patients die before a culture
diagnosis is made. This project aims to reduce Tm mortality by introducing a novel sensitive antigen
detection method and by testing an innovative concept that will enable early disease screening and
treatment. We have preliminary data that a novel enzyme immunoassay (EIA) detecting a Tm-specific
abundantly-released cell wall protein Mp1p is highly specific and is more sensitive than blood culture
for Tm detection. This project will drive the translation of this new technology into improving patient
care, testing its clinical utility as a rapid diagnostic test, and establishing a proof of concept that infection
can be identified early during pre-clinical stage. This would create new opportunities for disease
screening and prevention strategies. To do this, we will establish a cohort of febrile AIDS patients for
the evaluation of diagnosis utility and will establish a cohort of asymptomatic AIDS patients starting
HIV therapy for evaluation of early disease detection. We will test the following hypotheses: 1) the
Mp1p EIA is at least 20% more sensitive than conventional cultures and reduces time to diagnosis; 2)
Mp1p antigen precedes development of talaromycosis in asymptomatic patients and is associated with
morbidity and all-cause mortality; 3) the Mp1p EIA has similar sensitivity and specificity in the urine
compared to plasma/sera samples of patients. We have established a team of investigators from Duke
University, University of Hong Kong, and Oxford University Clinical Research Unit and its partner
hospitals in Vietnam with expertise and experience in the development and clinical evaluation of
diagnostics. Upon completion of the project, we expect to provide robust data to support the integration
of the Mp1p EIA into routine Tm diagnostic algorithm. Data generated from these studies have the
potential to shift the current treatment paradigm from treating advanced disease to preventing disease
development through a screen-and-treat approach. We expect our strategy will substantially impact
disease burden.

## Key facts

- **NIH application ID:** 10190805
- **Project number:** 5R01AI143409-03
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Thuy Le
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $594,989
- **Award type:** 5
- **Project period:** 2019-07-16 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10190805

## Citation

> US National Institutes of Health, RePORTER application 10190805, Making an early diagnosis of talaromycosis - an approach to reduce morbidity and mortality in advanced HIV disease in Southeast Asia (5R01AI143409-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10190805. Licensed CC0.

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