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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT02674867
Eligibility Criteria:
Inclusion Criteria:
* 5 to 17 years old
* Vertically HIV-1 infected, not HIV-2 co-infected
* Diagnosed \< 13 years old
* Usually followed in a center participating in the ANRS CO10 EPF cohort located in Ile de France
* Have received cART treatment:
* started later than 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group)
* with an initial virologic success (HIV-1 RNA \<400 copies / mL reached no later than 24 months after the start of cART),
* Affiliated person or beneficiary of a social security system (Article L1121-11 of the Code of Public Health) (medical aid of state or AME is not a social security system)
* Participant agreement if in age to give an opinion
* Free, informed and written consent, signed by at least one parent and the investigator
Exclusion Criteria:
* \< 5 years old or ≥ 18 years old at first sample for the study
* Obviously HIV-1 infected after the perinatal period
* HIV-2 co-infected
* Diagnosed ≥ 13 years old
* Started cART treatment between 7 and 23 months
* No HIV-1 RNA \<400 copies / mL within 24 months after initiation of treatment (considered as a failure of the first line therapy)
* Not affiliated to the French social security, or beneficiary of a social security system
* Refusal to participation of parent(s) (or the holders(s) of parental authority)
* Refusal to participation if in age to give an opinion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT02674867
Study Brief:
Protocol Section:
NCT02674867