Detection of Specific Metabolic Signatures by Nuclear Magnetic Resonance or Metabolomic NMR in Correlation With Markers of Inflammation or Immune Activation and the Risk of Developing Neurocognitive Disorders - Longitudinal Retrospective Study Nested in the ANRS12225 PEDIACAM III Cohort

NCT07770568 | Not Yet Recruiting

• 1 other identifier: ANRS0213s MIND
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

The ANRS12225 PEDIACAM III cohort involves a cohort of young adolescents living with HIV placed early (median: 4 months) on antiretroviral therapy (ART) and living without HIV monitored in Cameroon. This cohort follows the evolution of the psychomotor development of children living with HIV by mother-to-child transmission under antiretroviral treatment (ART) since birth as part of the cohort between 2016-2017 in children aged 4-9 years (ANRS12322 -PEDIACAMDEV) using the KABC II (Kaufman Assessment Battery for Children II). Despite early ART, children with HIV had significantly lower cognitive scores than uninfected children. Multiple neurodevelopmental studies have shown that intrauterine infection or even low- noise inflammation could impact the development of a child's brain allowing cognitive impairment to appear later in life. Other studies have also shown that metabolic defects could be the cause of chronic inflammation and immune activation. Admittedly, many studies have been carried out in cohorts of HIV-positive adults as well as HIV-positive children on neurological disorders. But very few have made the link between metabolism, inflammation, immune activation and neurocognitive disorders in infants and children in countries with limited resources. The ANRS12225 PEDIACAM III cohort offers the unique opportunity in Africa to carry out a study in a population of children living with HIV matched with a population of children living without HIV born to HIV + mothers and children living without HIV born to HIV-infected mothers in follow-up longitudinal. To explore this area, this pilot project will make it possible to assess the relevance of a cutting-edge, highthroughput technique, metabolomic NMR (Nuclear magnetic resonance), to quantify metabolites and lipoproteins in plasma and study their predictive value for the appearance of Neurodevelopmental disorders in children of different groups of the ANRS12225 PEDIACAM III cohort. It is intended to be completed within a short period (18 months) in order to be continued by more ambitious projects

Conditions

HIV Infection

Keywords

Metabolic Signature; Children; HIV; NMR-Basedmetabolomics; Immune activation; Neurodevelopment

Outcome Measures

Primary Outcomes (3)

• Verification of the presence of metabolic defects early from the first months of life (comparison between the different study groups independently of the correlation with neurocognitive disorders).

  18 month

• Demonstration of a probable correlation between these metabolic defects and other inflammatory markers or immune activation and especially with neurocognitive disorders

  18 month

• information on the development time of the metabolic defect and its persistence through longitudinal monitoring, even if it only covers 3 points in this pilot study,

  18 month

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The children included in this study are those from the ANRS 12225 - Pediacam III cohort who participated in the ANRS 12322 - PediacamDEV study (2016 - 2017).. According to the results of the KABC II, our study population is divided in three group: Group 1: HIV-infected children on ART (N=62) Group 2: HIV-uninfected children born to HIV-positive mothers (N=31) Group 3: HIV-uninfected children born to HIV-negative mothers (N= 35) With 3 sampling points on different dates for each child, the total number of samples to be processed will be N= 384 samples.

You may qualify if:

• Any infected or uninfected child in the ANRS 12225 Pediacam III cohort who participated in the ANRS 12322 - PediacamDev study on the evaluation of neurocognitive development and who had the results of the KABC II test (IPM and INV).
• Children still followed in the ANRS cohort - Pediacam III having participated in the ANRS 12322 study - PediacamDev having results of the KABC II test (IPM and INV) and having plasma samples and never thawed in sufficient quantity (500 microliter) ; at different times of longitudinal follow-up: at 6 (±1.5) months and 12 (± 3) months, and at 108 (± 6) months.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut Pasteur: collaborator
• Centre Pasteur du Cameroun: collaborator
• Université Paris Cité: collaborator
• Hopital Universitaire Robert-Debre: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples from children followed in the ANRS 12225 Pediacam III cohort will be used in this study. These never-thawed plasma samples (primary criterion for the NMR-metabolomics study) are available in sufficient quantity (500 microlitre) for NMR-metabolomics analysis and ELISA analyzes of inflammatory markers, activation and mitochondrial defects (mitokines) at different times of longitudinal follow-up: at 6 (±1.5) months and 12 (± 3) months, and at 108 (± 6) months. With 3 sampling points on different dates for each child, the total number of samples to be processed will be N= 384 samples

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Mathurin C Tejiokem, Doctor

CONTACT

00237222231803; tejiokem@pasteur-yaounde.org

Mireille Laforge, Doctor

CONTACT

mireille.laforge@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share