AIDS/HIV - RelatedDisease Associated With AIDSNCT04033120
Making an Early Diagnosis of Talaromycosis Using a Novel Antigen Test
An observational study of AIDS/HIV - RelatedDisease Associated With AIDS, run by Duke University at 2 sites in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS/HIV - RelatedDisease Associated With AIDS
- How many people
- 1,411 participants
- Where
- 2 sitesVietnam
- Study dates
- 22 Feb 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- Unlikely to attend regular clinic visits
- History of recent talaromycosis or histoplasmosis infection currently on antifungal therapy
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
National Hospital for Tropical Diseases
Hà Nội
Hospital for Tropical Diseases
Ho Chi Minh City, Ward 1 District 5
About this study
Official title: Making an Early Diagnosis of Talaromycosis - a Strategy to Reduce Morbidity and Mortality in Advanced HIV Disease in Southeast Asia
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.
Read the 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 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:
- In symptomatic hospitalized patient Cohort 1, the sensitivity of the Mp1p EIA will be higher than conventional culture method while simultaneously specificity is higher than 95% for diagnosing culture-confirmed talaromycosis over a six-month follow up period
- In asymptomatic outpatient Cohort 2, there will be at least 30% difference in risk of talaromycosis development in TmAg-positive patients compared to TmAg-negative patients over a twelve-month follow up period
- TmAg concentration predicts development of talaromycosis
Secondary Objectives include:
- To assess the impact of presence of TmAg on clinical outcomes, including development of culture-confirmed talaromycosis, incidence of state III and IV AIDS events, subsequent hospitalizations, and death over six- to twelve-month follow up periods
- 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:
- To model the health economic benefits of screening and pre-emptive treatment for pre-clinical infection
- To assess impact on clinic outcomes of screening all patients for cryptococcosis and histoplasmosis
- To collect additional blood samples and store left-over samples for future research to validate infectious disease diagnostics and research to understand genetic susceptibility to infectious diseases relevant to HIV population
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.
- Keywords
- HIV, talaromycosis, endemic mycoses, opportunistic infections, penicilliosis, Southeast Asia
- Medical subject headings
- talaromycosis, Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 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 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over six to twelve months
Secondary outcomes (5)
Incidence of other major HIV-associated opportunistic infections
Opportunistic infections to be recorded include: tuberculosis, cryptococcosis, and histoplasmosis
Measured: 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
Measured: over six to twelve months
Hospitalizations in the subsequent six to twelve months
Cumulative incidence of hospitalizations
Measured: over six to twelve months
Mortality in the subsequent six months (Cohort 1) and twelve months (Cohort 2)
All cause mortality will be recorded
Measured: over six to twelve months
Incidence of loss to follow up
Loss of follow up is defined as missing >3 consecutive clinic visits
Measured: over six to twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start22 Feb 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AIDS/HIV - RelatedDisease Associated With AIDSStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Clinical Research Unit, Vietnam, National Hospital for Tropical Diseases, Hanoi, Vietnam, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, The University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Thuy Le, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033120
- Sponsor's protocol ID
- Pro00102384
- Status last verified
- Feb 2025
- First submitted
- 23 Jul 2019
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thu NTM, Chan JFW, Ly VT, Ngo HT, Hien HTA, Lan NPH, Chau NVV, Cai JP, Woo PCY, Day JN, van Doorn R, Thwaites G, Perfect J, Yuen K, Le T. Superiority of a Novel Mp1p Antigen Detection Enzyme Immunoassay Compared to Standard BACTEC Blood Culture in the Diagnosis of Talaromycosis. Clin Infect Dis. 2021 Jul 15;73(2):e330-e336. doi: 10.1093/cid/ciaa826.
PubMed 32564074
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making an Early Diagnosis of Talaromycosis - a Strategy to Reduce Morbidity and Mortality in Advanced HIV Disease in Southeast Asia
- ClinicalTrials.gov ID
- NCT04033120
- Acronym / sponsor ID
- Pro00102384
- Keywords
- HIV, talaromycosis, endemic mycoses, opportunistic infections, penicilliosis, Southeast Asia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,411 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Oxford University Clinical Research Unit, Vietnam, National Hospital for Tropical Diseases, Hanoi, Vietnam, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, The University of Hong Kong
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- In symptomatic hospitalized patient Cohort 1, the sensitivity of the Mp1p EIA will be higher than conventional culture method while simultaneously specificity is higher than 95% for diagnosing culture-confirmed talaromycosis over a six-month follow up period
- In asymptomatic outpatient Cohort 2, there will be at least 30% difference in risk of talaromycosis development in TmAg-positive patients compared to TmAg-negative patients over a twelve-month follow up period
- TmAg concentration predicts development of talaromycosis
Secondary Objectives include:
- To assess the impact of presence of TmAg on clinical outcomes, including development of culture-confirmed talaromycosis, incidence of state III and IV AIDS events, subsequent hospitalizations, and death over six- to twelve-month follow up periods
- 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:
- To model the health economic benefits of screening and pre-emptive treatment for pre-clinical infection
- To assess impact on clinic outcomes of screening all patients for cryptococcosis and histoplasmosis
- To collect additional blood samples and store left-over samples for future research to validate infectious disease diagnostics and research to understand genetic susceptibility to infectious diseases relevant to HIV population
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –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 | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Unlikely to attend regular clinic visits
- History of recent talaromycosis or histoplasmosis infection currently on antifungal therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of microscopy and/or culture-confirmed talaromycosis
Time frame: over six to twelve months
Cumulative incidence of microscopic and or culture-confirmed talaromycosis over six to twelve months will be recorded
5 secondary outcomes
Incidence of other major HIV-associated opportunistic infections
Time frame: over six to twelve months
Incidence of stage III and IV AIDS events
Time frame: over six to twelve months
Hospitalizations in the subsequent six to twelve months
Time frame: over six to twelve months
Mortality in the subsequent six months (Cohort 1) and twelve months (Cohort 2)
Time frame: over six to twelve months
Incidence of loss to follow up
Time frame: over six to twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 32564074Thu NTM, Chan JFW, Ly VT, Ngo HT, Hien HTA, Lan NPH, Chau NVV, Cai JP, Woo PCY, Day JN, van Doorn R, Thwaites G, Perfect J, Yuen K, Le T. Superiority of a Novel Mp1p Antigen Detection Enzyme Immunoassay Compared to Standard BACTEC Blood Culture in the Diagnosis of Talaromycosis. Clin Infect Dis. 2021 Jul 15;73(2):e330-e336. doi: 10.1093/cid/ciaa826.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thuy Le, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS/HIV - RelatedDisease Associated With AIDS, run by Duke University at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of microscopy and/or culture-confirmed talaromycosis (time frame: over six to twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04033120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.