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:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT02043769
Eligibility Criteria:
Inclusion Criteria:
* The child is eligible for antiretroviral therapy (ART) initiation based on the South African Pediatric HIV guidelines.
* The child has documentation of being HIV-infected by a positive HIV-Deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), detectable HIV ribonucleic acid (RNA) viral load or a positive HIV antibody test (\>18 months of age).
* The child has no prior history of treatment with ART other than prophylaxis for preventing mother to child transmission (PMTCT) (may be initiating ART on day of enrollment in study).
* The child is between 1 month and 12 years of age.
* The parent or legal guardian provides written consent for participation.
* The child provides assent for participation based on South African guidance for minors.
Exclusion Criteria:
* Any subject not meeting all of the above inclusion criteria will not be eligible for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
12 Years
Study:
NCT02043769
Study Brief:
Protocol Section:
NCT02043769