CompletedNot Applicable

Making an Early Diagnosis of Talaromycosis Using a Novel Antigen Test

Vietnam1,411 participantsStarted 2021-02-22

Plain-language summary

This is a research study to determine whether a new antigen detection test called Mp1p EIA can make an early diagnosis of talaromycosis from the blood and urine of patients. Talaromycosis is a life-threatening infection caused by a fungus endemic in Southeast Asia commonly found in patients with advanced HIV disease called Talaromyces marneffei.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. HIV-1 infection (at least 2 of 3 HIV antibody tests are positive), AND
✓. HIV-infected age ≥18 years, AND
✓. CD4 count ≤100 cells/mm3 within the past 3 months, AND
✓. Antiretroviral therapy (ART) naïve OR recent ART ≤3 months OR suspected or confirmed treatment failure on ART ≥12 months (defined as poor treatment adherence, treatment interruption, or having a confirmed HIV RNA ≥1,000 copies)
✓. Cohort 1: suspected to have an active infection
✓. Cohort 2: not suspected to have or being evaluated for an active infection

Exclusion criteria

✕. Unlikely to attend regular clinic visits
✕. History of recent talaromycosis or histoplasmosis infection currently on antifungal therapy

What they're measuring

Incidence of microscopy and/or culture-confirmed talaromycosis

Timeframe: over six to twelve months

Trial details

NCT IDNCT04033120

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More AIDS/HIV - RelatedDisease Associated With AIDS trials