Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT06302933
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2023-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
Official Title:
Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PediacamNEG
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.
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.
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
* 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: