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Status unknownNCT06302933PediacamNEGUpdated Jan 30, 2025

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

An interventional study of Blood sampling in HIV Infections, sponsored by ANRS, Emerging Infectious Diseases. Status unknown at 3 sites in Cameroon. Per ClinicalTrials.gov, last updated 2025-01-30.

Sponsored by ANRS, Emerging Infectious Diseases · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
451
Allocation
Not applicable
Sex
All
01

Study 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.
Read the 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
02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 451 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.

Browse ANRS, Emerging Infectious Diseases studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
451 participants (estimated)

Study arms

  • Other
    Children enrolled in Pediacam III ANRS12225 cohort

    Biological: Blood sampling

Interventions

  • BiologicalBlood sampling

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

06

What researchers measure

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

  5. 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.

    Time frame: 18 months

  6. 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.

    Time frame: 18 months

  7. 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

    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

  5. - Level of HIV plasma p24

    Measure plasma level of HIV p24 antigen (fg/ml) using ultrasentsitive technique called Simoa (Single molecule array)

    Time frame: 18 months

  6. - HLA phenotype and the KIR genotypes

    HLA-B (27 et 57), HLA-B35 ou 53, HLA-C16:01+KIR2DL3+

    Time frame: 18 months

07

Study locations

2 of 3 sites recruiting
  • 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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Aug 2025, 15 months after the start.

Of 549 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 15 months is below that.

Counting every sponsor, half of 559 studies reached it within 28 months; a quarter within 16 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2023
First posted
Mar 12, 2024
StartActual
May 2, 2024
Primary completionEst.
Aug 30, 2025
CompletionEst.
Aug 30, 2025
Last update
Jan 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06302933
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Centre Pasteur du Cameroun, Centre Mère et Enfant de la Fondation Chantal Biya, Centre Hospitalier D'essos, Hospital General De Douala, CH Orléans, Institut Pasteur, Hopital Universitaire Robert-Debre, Université Paris-Sud
Responsible party
Sponsor
First posted
Mar 12, 2024
Start date
May 2, 2024
Primary completion
Aug 30, 2025 (estimated)
Completion
Aug 30, 2025 (estimated)
Last update
Jan 30, 2025

Study contacts

Mathurin C Tejiokem, Doctor
Contact
tejiokem@pasteur-yaounde.org
00237222231803
Albert Faye, Doctor
Contact
albert.faye@rdb.ap-hop-paris.fr
0033140035361

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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