NCT04033120Completed
Making an Early Diagnosis of Talaromycosis Using a Novel Antigen Test
Making an Early Diagnosis of Talaromycosis - a Strategy to Reduce Morbidity and Mortality in Advanced HIV Disease in Southeast Asia
Source: ClinicalTrials.gov · Last updated 7 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1411 (actual)
- First submitted
- 23 Jul 2019
- Start date
- 22 Feb 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Duke University
- Diseases
- HIV
- NCT number
- NCT04033120
What you commit to
- Study type: Observational
- Participants enrolled: 1411
- From 22 Feb 2021 to the primary completion date, 31 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of recent talaromycosis or histoplasmosis infection currently on antifungal therapy
Other
- Unlikely to attend regular clinic visits
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Hospital for Tropical Diseases Coordinator of this site? Confirm its status | Hà Nội | Vietnam | Unknown status |
| Hospital for Tropical Diseases Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.