Skip to content

Host gene-expression in blood for the diagnosis and monitoring of active tuberculosis among HIV infected individuals: Prospective cohort study

Host gene-expression in blood for the diagnosis and monitoring of active tuberculosis among HIV infected individuals: Prospective cohort study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20210205006
Enrollment
200
Registered
2021-02-05
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Host gene-expression for the diagnosis and monitoring of active tuberculosis among HIV infected individuals Host gene-expression, Gene expression diagnosis, HIV infected with TB, TB gene expression

Interventions

HIV infected patient older than equal 18 years old who has suspected of TB infected assessed from chest X-ray examination and clinical manifestations as following: - Negative sputum AFB smear or sputu
Diagnostic,Diagnostic,Diagnostic
Active TB,Latent TB,HIV healthy

Sponsors

National Research Council of Thailand (NRCT)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. HIV infected participant 1.1 HIV with active TB group - HIV infected patient older than equal 18 years old - Documented HIV infection in reference to diagnosis standard of Thailand. - Confirmed diagnosis of pulmonary or extrapulmonary active TB from clinical manifestations, chest X-ray examination, or radiology findings. - Positive or Negative sputum AFB smears - Confirmed diagnosis of TB including but not limited to histology or pathology findings and sputum culture or positive of M. tuberculosis from gene Xpert TB/RIF analysis. - Patients receiving treatment of TB not exceeding 4 weeks. 1.2 HIV with latent TB group - HIV infected patient older than equal 18 years old - Documented HIV infection in reference to diagnosis standard of Thailand. - Asymptomatic or not presence of TB clinical manifestations - Confirmed diagnosis of latent TB by Tuberculin skin test (TST) indurated greater than 5 mm or positive interferon gamma release assay (IGRA) within previous 2 years and no history of TB diagnosis or not receiving any medications of latent TB treatment. 1.3 HIV healthy group - HIV infected patient older than equal 18 years old - Documented HIV infection in reference to diagnosis standard of Thailand. - No presence of active TB from chest X-ray examination and Tuberculin skin test (TST) indurated less than 5 mm and negative interferon gamma release assay (IGRA) within 6 months. 2. Properly completed patient informed consent in writing. 3. The participants are willing to comply with the study procedure throughout the study period.

Exclusion criteria

Exclusion criteria: The presence of any significant increase in harm risk to participants or participants did not follow the study procedure.

Design outcomes

Primary

MeasureTime frame
Group of gene expression for active TB diagnosis in HIV infected patient 0 Droplet Digital PCR

Secondary

MeasureTime frame
Group of gene expression for TB treatment response monitoring in HIV infected patient 0 Droplet Digital PCR

Countries

Thailand

Contacts

Public ContactSivaporn Gatechompol

The Thai Red Cross Society

sivaporn.k@hivnat.org026523040

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026