NCT06302933

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
451

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

January 30, 2025

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

August 24, 2023

Last Update Submit

January 28, 2025

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (7)

  • 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.

    18 months

  • 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.

    18 months

  • 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.

    18 months

  • 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.

    18 months

  • Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma

    Measure of IL-10 (pg/ml). Levels of these biomarkers will be compared across all groups.

    18 months

  • Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma

    Measure of IP-10 (pg/ml). Levels of these biomarkers will be compared across all groups.

    18 months

  • Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma

    Measure of TRAIL (ng/ml). Levels of these biomarkers will be compared across all groups

    18 months

Secondary Outcomes (6)

  • - Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B

    18 months

  • - Functional and phenotypic characterization of B and T lymphocytes

    18 months

  • - Size of the HIV reservoir

    18 months

  • - Residual viremia in perinatally HIV-infected adolescent

    18 months

  • - Level of HIV plasma p24

    18 months

  • +1 more secondary outcomes

Study Arms (1)

Children enrolled in Pediacam III ANRS12225 cohort

OTHER
Biological: Blood sampling

Interventions

Blood samplingBIOLOGICAL

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

Children enrolled in Pediacam III ANRS12225 cohort

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital de Jour - Hôpital Laquintinie de Douala

Douala, 4035, Cameroon

NOT YET RECRUITING

Unité Pédiatrique de Jour - Centre Mère et Enfant de la Fondation Chantal Biya

Yaoundé, 1274, Cameroon

RECRUITING

Service de Pédiatrie - Centre Hospitalier d'Essos

Yaoundé, 5777, Cameroon

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Mathurin C Tejiokem, Doctor

CONTACT

00237222231803tejiokem@pasteur-yaounde.org

Albert Faye, Doctor

CONTACT

0033140035361albert.faye@rdb.ap-hop-paris.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2023

First Posted

March 12, 2024

Study Start

May 2, 2024

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

January 30, 2025

Record last verified: 2024-06

Locations

CA(3)