An observational study in AIDS/HIV - RelatedDisease Associated With AIDS, sponsored by Duke University. Completed at 2 sites in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Duke University · Observational
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.
This study aims to determine the diagnostic and prognostic values and the clinical impact of Talaromyces marneffei antigenemia (TmAg) in patients with advanced HIV disease using a novel enzyme immunoassay (EIA) detecting Tm-specific cell wall mannoprotein Mp1p. The data generated will be used to inform the design of future diagnostic clinical trials to test the utility of screening and providing pre-emptive antifungal therapy to prevent disease and reduce HIV mortality in Southeast Asia.
The primary objective is to screen for TmAg and determine its diagnostic and prognostic performance in symptomatic and asymptomatic HIV-infected patients with a CD4 count ≤100 cells/mm3.
We will test the following hypotheses:
Secondary Objectives include:
To compare the diagnostic values of the Mp1p EIA when performed in plasma, sera, and urine samples and when performed in these matrices in combination
We will test the following hypotheses:
Participants in the study, will be asked questions about their medical and travel history. Participants will have blood and urine collected for the Mp1p EIA test to look for early talaromycosis infection and for other tests to look for common HIV-associated infections including tuberculosis, cryptococcosis, and histoplasmosis. They will be examined by a study doctor at least once weekly if they are in the hospital and will be followed in clinic monthly for between 6 and 12 months.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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HIV-infected patients age ≥18 years with advanced HIV disease who have a CD4 count ≤100 cells/mm3 within the past 3 months, who are admitted to hospitals with a suspected infection (Cohort 1) or who are asymptomatic and registered in HIV outpatient clinic (Cohort 2) in Vietnam
Exclusion Criteria:
Cohort 1: Symptomatic hospitalized patients: 900 patients admitted to the participating hospitals whom doctors suspect to have an infection and will perform TmAg testing alongside routine diagnostics and the following additional diagnostics: 1. MycoF/lytic blood culture system 2. Fujifilm lateral flow urine lipoarabinomannan (LF-LAM) test for tuberculosis 3. Cryptotoccoal antigen in sera (CrAg) LFA for cryptococcosis 4. Histoplasma antigen in urine (HAg) LFA for histoplasmosis We will follow patients closely for early diagnosis and treatment of culture confirmed talaromycosis over a six-month follow up period
Cohort 2: Asymptomatic outpatients: 500 patients registered at the outpatient clinics at the participating hospitals whom doctors do not suspect of having an active infection and will perform TmAg testing alongside the following diagnostics: 1. CrAg LFA for cryptococcosis 2. HAg LFA for histoplasmosis We will follow patients closely for early diagnosis and treatment of culture confirmed talaromycosis over a twelve-month follow up period.
Incidence of microscopy and/or culture-confirmed talaromycosis
Cumulative incidence of microscopic and or culture-confirmed talaromycosis over six to twelve months will be recorded
Time frame: over six to twelve months
Incidence of other major HIV-associated opportunistic infections
Opportunistic infections to be recorded include: tuberculosis, cryptococcosis, and histoplasmosis
Time frame: over six to twelve months
Incidence of stage III and IV AIDS events
Cumulative incidence of HIV stage III and IV event according to WHO criteria
Time frame: over six to twelve months
Hospitalizations in the subsequent six to twelve months
Cumulative incidence of hospitalizations
Time frame: over six to twelve months
Mortality in the subsequent six months (Cohort 1) and twelve months (Cohort 2)
All cause mortality will be recorded
Time frame: over six to twelve months
Incidence of loss to follow up
Loss of follow up is defined as missing \>3 consecutive clinic visits
Time frame: over six to twelve months
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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