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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01107834
Eligibility Criteria:
Inclusion Criteria:
1. Age 5-12 years
2. Tanner stage I-III
3. Born to HIV+ mother
4. No HIV infection
5. Had taken standard of care prophylactic HAART at birth-1 month of age
6. Child currently not taking medications or have medical diagnosis that would affect left ventricular function
7. Mother was taking HAART during pregnancy (standard of care)
8. Mother was not using illegal drugs during pregnancy
9. No intrauterine growth restriction diagnosis during pregnancy
10. During pregnancy, mother will not have a diagnosis of type 2 diabetes or gestational diabetes.
Exclusion Criteria:
1. Age 5-12 years
2. Tanner stage I-III
3. Born to HIV-negative mother
4. Mother was not a frequent exerciser during pregnancy (\>2x/week)
5. Mother will not have gestational diabetes or a diagnosis of type 2 diabetes during pregnancy of the child being studied
6. Child currently not taking medications or have medical diagnosis that would affect left ventricular function
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT01107834
Study Brief:
Protocol Section:
NCT01107834