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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT04024150
Eligibility Criteria:
Inclusion Criteria:
* No parental opposition after information. "Exposed" group :
* Newborn at term exposed to raltegravir (RTG) before 8 weeks of gestation and until the end of pregnancy. Children exposed to elvitegravir (ETG), dolutegravir (DTG) or bictegravir (BTG) may be included but will be analyzed separately.
"Control" group :
\- Term neonate exposed to antiretroviral therapy without anti-integrase.
Exclusion Criteria:
* Prematurity less than 36 weeks of gestation.
* Organ dysfunction.
* Acute or chronic fetal distress, need for hospitalization in neonatology, malformation syndrome.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04024150
Study Brief:
Protocol Section:
NCT04024150