Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antir… (NCT06302933) | Clinical Trial Compass
RecruitingNot Applicable
Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
Cameroon451 participantsStarted 2024-05-02
Plain-language summary
The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in Cameroon
The hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives:
* Immunological aspect: lack of humoral response or immune activation
* Virological aspect: Reduced HIV reservoir size
* Determine the HLA phenotype in the different groups of children included and the KIR genotypes.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Case control study
* Children included and followed in the ANRS 12225 study - Pediacam III
* Having plasma samples in the bio bank during the above-mentioned periods Case:children with at least one negative HIV serology made by ELISA, permanent or transientduring follow-up.
Control (4 groups)
* HIV-infected children with positive serology and viral load (VL) \<400 copies /ml
* HIV-infected children with positive serology and VL ≥400 copies / ml
* HIV-uninfected children born to HIV-positive mothers
* HIV-uninfected children born to HIV-uninfected mothers Selection of cases and controls will be matched on gestational age (premature \<37, term ≥37 weeks) and year of birth (2007-2008 and 2009-2010).
Cross sectional study Inclusion criteria
* All children still followed in the ANRS - Pediacam III cohort
* Written consent of one of the parents or the guardian and assent of the child if aged ≥ 11 years and complete disclosure of HIV statusfor infected children for participation to the study.
Exclusion Criteria:
* Refusal by one of the parents or the guardian for the child's participation in the study
* No assent of the child (if aged ≥ 11 years and with complete disclosure of HIV status, for infected children)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Timeframe: 18 months
2
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Timeframe: 18 months
3
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Timeframe: 18 months
4
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Timeframe: 18 months
5
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Timeframe: 18 months
6
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Timeframe: 18 months
7
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma