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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT00351702
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 15 years
2. HIV positivity (on 2 different ELISA tests on the same blood sample)
3. Living in Chennai or Madurai within a defined area of intake - 25 km radius.
4. Likely to remain in the same area for at least three years after start of treatment
5. The patient is judged to be cooperative and willing for fortnightly attendance for the next 3 years
6. Is agreeable for home visits
7. No major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease.
8. No other medical condition that might interfere with management like diabetes, convulsions, serious cardiac disease.
9. Patients who fulfill laboratory criteria (hemoglobin \> 7.0g/l,granulocyte count\>11,000/l, platelet count \> 1 lakh/l. serum alanine amino transferase concentration \< 2.5 times the upper limit of normal and serum creatinine concentration \< 1.1 mgs%, random blood sugar \< 140 mgs%) will be enrolled into the study.
Exclusion Criteria:
1. Resides outside area of intake.
2. Pregnancy and lactation.
3. Patients with major psychiatric illnesses and severe depression
4. Major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease
5. Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, convulsions, cancer, moribund state
6. Previous antituberculosis treatment for more than 1 month
7. Patients on ART -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
60 Years
Study:
NCT00351702
Study Brief:
Protocol Section:
NCT00351702