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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02119702
Eligibility Criteria:
Perinatally HIV-Infected Cohort
Inclusion Criteria:
* Perinatal HIV infection as documented in the medical record
* At or beyond their 18th birthday at the time of informed consent with no upper age limit
* Willing to provide access to existing medical records
* Available medical record documentation since early childhood of:
* ART exposure history
* Opportunistic infection prophylaxis exposure history
* Viral load and CD4+ cell count history
* Major medical events history
* Willingness to participate and provide legal written consent
Exclusion Criteria:
* HIV acquired by other than maternal-child transmission (e.g., blood products, sexual contact, and IV drug use) as documented in the medical record
Uninfected Cohort
Inclusion Criteria:
* Absence of perinatal HIV infection as indicated in the medical record; the Perinatally HIV-Exposed Uninfected (PHEU) participant may have horizontally-acquired HIV infection
* At or beyond their 18th birthday at the time of informed consent with no upper age limit
* Willingness to participate and provide legal written consent
Exclusion Criteria:
* Have confirmed perinatal HIV infection as documented in the medical record
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02119702
Study Brief:
Protocol Section:
NCT02119702