Clinical trial NCT06302933: Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
Official title: Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Centre Pasteur du Cameroun
name: Centre Mère et Enfant de la Fondation Chantal Biya
name: Centre Hospitalier D'essos
name: Hospital General De Douala
name: CH Orléans
name: Institut Pasteur
name: Hopital Universitaire Robert-Debre
name: Université Paris-Sud
First posted: 2024-03-12
Enrollment: 451
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study type: a study nested in the ANRS 12225 - Pediacam III cohort, comprising two phases

* A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.
* A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: There will be two phases of the study :

* A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.
* A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank

Eligibility criteria: 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)

Primary outcomes:
measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
timeFrame: 18 months
measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
timeFrame: 18 months
measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
timeFrame: 18 months
measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
timeFrame: 18 months
measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
timeFrame: 18 months
measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
timeFrame: 18 months
measure: Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
timeFrame: 18 months
Secondary outcomes:
measure: - Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B
timeFrame: 18 months
measure: - Functional and phenotypic characterization of B and T lymphocytes
timeFrame: 18 months
measure: - Size of the HIV reservoir
timeFrame: 18 months
measure: - Residual viremia in perinatally HIV-infected adolescent
timeFrame: 18 months
measure: - Level of HIV plasma p24
timeFrame: 18 months
measure: - HLA phenotype and the KIR genotypes
timeFrame: 18 months
Other outcomes:
Locations:
city: Douala
country: Cameroon
facility: Hôpital de Jour - Hôpital Laquintinie de Douala
city: Yaounde
country: Cameroon
facility: Unité Pédiatrique de Jour - Centre Mère et Enfant de la Fondation Chantal Biya
city: Yaoundé
country: Cameroon
facility: Service de Pédiatrie - Centre Hospitalier d'Essos
Study officials:
References: