Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT01782950
Eligibility Criteria:
Inclusion Criteria:
* Evidence of a personally signed and dated informed consent
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Age of ≥18 years
* First episode of pulmonary TB i.e. proven or highly suspected TB considered for TB treatment qualifying for 6 months anti-Tb drugs regimen
* Confirmed HIV-1 infection
Exclusion Criteria:
* Unable to provide informed consent
* Documented or highly suspected TB infection of any organs/systems other than the lung requiring TB treatment longer than 6 months
* Previously treated for a mycobacterial infection (TB or atypical mycobacterial infection, active or latent)
* Pregnancy or planned pregnancy within the next year
* Unwillingness to perform pregnancy test
* Decompensated liver disease and/or aminotransferases \>5x ULN
* GFR \< 50 ml/min
* Co-morbidities reducing life expectancy to \<1 year (e.g. cancer)
* Patient wishes to take part in another interventional study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01782950
Study Brief:
Protocol Section:
NCT01782950