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

ConditionHIV Infection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-18
SponsorANRS, Emerging Infectious Diseases

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
18 month
2

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

Time frame
18 month
3

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,

Time frame
18 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

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

Institut Pasteur

Collaborator

Hopital Universitaire Robert-Debre

Collaborator

Université Paris Cité

Collaborator

This trial is not recruiting at the moment. You can still explore other options: