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 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT00023361
Eligibility Criteria:
Inclusion Criteria
* Clinical diagnosis of pulmonary \&/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen
* Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot).
* Absolute neutrophil count \>500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed)
* \> 18 years of age
* Willingness to practice effective contraception if applicable
* Signed informed consent
Exclusion Criteria
* Pregnancy or breastfeeding
* AST \> 10 times the upper limit of normal
* Bilirubin \> 3.0 times the upper limit of normal
* Creatinine \> 3.0 times the upper limit of normal
* Intolerance to any of the study drugs except isoniazid or pyrazinamide
* Concomitant disorder that is contraindication to the use of the study drugs
* More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy
* Bone/joint tuberculosis or silicotuberculosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00023361
Study Brief:
Protocol Section:
NCT00023361