Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorANRS, Emerging Infectious Diseases

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Blood sampling

    Biological/Vaccine

    Blood samples collected from children followed in the Pediacam III ANRS12225 cohort

Treatment groups

451 Participants
are divided into 1 treatment group
Group A: Children enrolled in Pediacam III ANRS12225 cohortOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months
2

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.

Time frame
18 months
3

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.

Time frame
18 months
4

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.

Time frame
18 months

Secondary outcomes

1

- 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

Time frame
18 months
2

- 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

Time frame
18 months
3

- 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)

Time frame
18 months
4

- Residual viremia in perinatally HIV-infected adolescent

Any detectable HIV-RNA below 50 copies/mL

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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