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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT01805258
Eligibility Criteria:
Inclusion Criteria:
1. HIV infection, documented by ELISA test
2. Adult patients
3. Patients co-infected with HIV and Tuberculosis
4. Concomitant use of Nevirapine and Rifampicin in patients co-infected with HIV and Tuberculosis
5. ART Naïve patients
Exclusion Criteria:
1. Allergy/hypersensitivity to any study drug(s).
2. Prior history of documented drug-resistant TB.
3. Pregnancy
4. Patients with alanine aminotransferase or aspartate aminotransferase levels more than five times the upper limit of normal.
5. Chronic liver disease due to cirrhosis of liver, hepatitis B \& C virus infection.
6. Chronic alcoholic.
7. Non-complaint patients.
8. Migrant patients.
9. Serious form of pulmonary or extrapulmonary tuberculosis e.g. severe haemoptysis and unconscious patients
10. Concomitant diabetes mellitus.
11. Epilepsy
12. Patients on other immunosuppressive therapy.
13. Malignancy other than Kaposi's Sarcoma requiring therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01805258
Study Brief:
Protocol Section:
NCT01805258