Status:
COMPLETED
Making an Early Diagnosis of Talaromycosis Using a Novel Antigen Test
Lead Sponsor:
Duke University
Collaborating Sponsors:
Oxford University Clinical Research Unit, Vietnam
National Hospital for Tropical Diseases, Hanoi, Vietnam
Conditions:
AIDS/HIV - RelatedDisease Associated With AIDS
Eligibility:
All Genders
18+ years
Brief 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-th...
Detailed Description
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 immunoa...
Eligibility Criteria
Inclusion
- 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
- Unlikely to attend regular clinic visits
- History of recent talaromycosis or histoplasmosis infection currently on antifungal therapy
Key Trial Info
Start Date :
February 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
1411 Patients enrolled
Trial Details
Trial ID
NCT04033120
Start Date
February 22 2021
End Date
December 31 2024
Last Update
February 7 2025
Active Locations (2)
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1
Hospital for Tropical Diseases
Ho Chi Minh City, Ward 1 District 5, Vietnam
2
National Hospital for Tropical Diseases
Hà Nội, Vietnam