About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
HIV-infected children with positive serology and viral load (VL) <400 copies /ml
HIV-infected children with positive serology and VL ≥400 copies / ml
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
Blood sampling
Biological/VaccineBlood samples collected from children followed in the Pediacam III ANRS12225 cohort
Treatment groups
Trial outcomes
Primary outcomes
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of sCD14 (µg/ml). Levels of these biomarkers will be compared across all groups.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of BAFF using luminex or commercially available ELISA quantification kits. Levels of these biomarkers will be compared across all groups.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of CXCL13 using luminex or commercially available ELISA quantification kits. Levels of these biomarkers will be compared across all groups.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of TNF-α (pg/ml). Levels of these biomarkers will be compared across all groups.
Secondary outcomes
- Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B
Serum concentrations of human IgG antibodies against tetanus-toxoid, pertussis, and viral hepatitis B will be measured using commercially available ELISA quantification kits and results will be given as IU/mL
- Functional and phenotypic characterization of B and T lymphocytes
Level (cells/μL or percentage) of T and B-cell lymphocytes subpopulations will be assess in blood using flow cytometry. Functional characterization of T and B lymphocytes will be done by cell culture following by cytokine production titration
- Size of the HIV reservoir
Measure total (copies/million PBMC), integrated (copies/million PBMC), unintegrated (copies/million PBMC) HIV DNA level in Peripheral Blood Mononuclear Cells (PBMC)
- Residual viremia in perinatally HIV-infected adolescent
Any detectable HIV-RNA below 50 copies/mL
Sponsors and contacts
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ANRS, Emerging Infectious Diseases
Lead sponsor
Centre Pasteur du Cameroun
Collaborator
Centre Mère et Enfant de la Fondation Chantal Biya
Collaborator
Centre Hospitalier D'essos
Collaborator
Hospital General De Douala
Collaborator
CH Orléans
Collaborator
Institut Pasteur
Collaborator
Hopital Universitaire Robert-Debre
Collaborator
Université Paris-Sud
Collaborator