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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT01699633
Eligibility Criteria:
Inclusion Criteria:
1. HIV seropositive children with or without active TB
2. Aged 3 to 35 months old
3. Antiretroviral-naïve and meet criteria for initiation of antiretroviral therapy
4. Are available for follow-up until achievement of a study endpoint like completion of study or discontinuation of HAART, and/or PK sampling
Exclusion Criteria:
1. Unable to obtain informed signed consent parent(s) or legal guardian
2. Have AIDS-related opportunistic infections other than TB, history of or proven acute hepatitis within 30 days of study entry, persistent vomiting, or diarrhea
3. Hemoglobin \< 6 g/dl, white blood cells \< 2500/mm3, serum creatinine \> 1.5 mg/dl, AST and ALT \> 2X upper limit of normal.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
35 Months
Study:
NCT01699633
Study Brief:
Protocol Section:
NCT01699633