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:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT00523458
Eligibility Criteria:
Inclusion Criteria:
* ARV naïve subjects
* Documented HIV infection
* Documented TB infection
* Platelet count 40,000/mm3
* Hemoglobin ≥8.0 g/dL
* Absolute neutrophil count (ANC) \>500/mm3
* AST (SGOT), ALT (SGPT), and alkaline phosphatase \<3 X ULN
* Total bilirubin \<2.5 x ULN
* Calculated creatinine clearance ≥60 mL/min
* For women of reproductive potential, negative urine pregnancy test
Exclusion Criteria:
* Unable to provide informed consent.
* History drug abuse that the investigators suspect will interfere with compliance to study medications and visits.
* Patients on hemodialysis.
* Tuberculosis meningitis.
* Women with CD4 \> 250 and men with CD4 \> 400 due to higher risk of hepatotoxicity related to use of NVP.
* Positive serology for hepatitis C.
* Evidence for active hepatitis B including positive serologies for HBsAg, HBeAg, or HBV-DNA. Note: If anti-HBs is positive, patient is eligible for study if liver enzymes are within the parameters indicated in the inclusion criteria
* Women who are breast-feeding
* Known allergy/sensitivity to study drug(s) or their formulations
* Patients with other OIs or intercurrent illness that could affect their ability to take study drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00523458
Study Brief:
Protocol Section:
NCT00523458