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Immunology of the Infection Perinatal

Immunology of the Infection Perinatal

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01055873
Acronym
EP38
Enrollment
93
Registered
2010-01-26
Start date
2007-02-28
Completion date
2009-02-28
Last updated
2010-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

immune status, adolescents or young adults infected, impact of viral replication

Brief summary

ANRS-EP38-IMMIP is a non interventional study. A single blood sample (30 mL) was drawn during a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood. Cells and plasma were stored and kept frozen for additional biological evaluations. Patients are included in the French perinatal cohort (ANRS CO-10), or have been followed since before 1996 in the same clinical sites as patients who belong to ANRS CO-10. In the ANRS CO-10 cohort, all patients are prospectively followed from birth.

Detailed description

Purpose: Efficient anti-retroviral treatments lead to a significantly increased life expectancy. Children with perinatal infection are now reaching adulthood. The deleterious impact of viral replication during ontogenesis of the immune system, and the high thymic activity during the early years of life, preclude an extrapolation from data pertaining to the adult immune status and mean that specific pediatric studies are required. No data are available concerning the immune status of adolescents or young adults infected via materno-foetal transmission. Detailed description: Our assumption is that the duration of uncontrolled viral replication will affect the immune status after treatment because viral replication is associated with: 1. disease progression independently of CD4+ T cell levels; 2. accelerated senescence of the immune system; 3. destruction of organs involved in the restoration of major immune cell populations. The aims of the study are: 1. to describe the immune and virological status of perinatally infected patients that are above 15 yrs old and 2. to study their associations with : 1. the current virological/clinical and therapeutic status, 2. the duration of uncontrolled viremia (defined by treatment history), 3. the virological, immunological (CD4+ numbers), and clinical status at time of HAART initiation. The immune status will be defined by (1) the number and phenotype of CD4+ and CD8+ T lymphocytes, dendritic cells, regulatory T cells, and NK cells, (2) the functions (proliferation and cytokine production) of CD4+ and CD8+ lymphocytes that are specific for HIV, a recall antigen (tetanus toxoid) and other viruses (CMV, EBV and Flu),the repertoire of Natural Killer cell receptors. The virological status will be defined by the level of HIV DNA in PBMCs, the HIV subtype, resistance mutations in archived and circulating virus and sequences of the regions of the viral envelope involved in co-receptor use. Clinical, therapeutic, demographic, virological and immunological data are collected from birth for members of the ANRS CO-10 cohort, and will be collected retrospectively since diagnosis for non-included patients.

Interventions

BIOLOGICALA single blood sample (30 mL)

A single blood sample (30 mL) was drawn during a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood. Cells and plasma were stored and kept frozen for additional biological evaluations

Sponsors

Institut Pasteur
CollaboratorINDUSTRY
University of Paris 5 - Rene Descartes
CollaboratorOTHER
Hôpital Necker-Enfants Malades
CollaboratorOTHER
French National Agency for Research on AIDS and Viral Hepatitis
Lead SponsorOTHER_GOV

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Being included in the ANRS CO-10 cohort, or being followed in the same sites as such patients since before 1996 * Being followed in the Paris area * HIV-1 infected through the perinatal route, and not HIV-2 co-infected * No therapeutic changes for at least 6 months; single molecule change without modification of viral load is tolerated. * Informed consent signed by the patients and by their legal guardians for those younger than 18. * Being affiliated to the

Exclusion criteria

French national social security system

Design outcomes

Primary

MeasureTime frame
To describe the immune and virological status of perinatally infected patients that are above 15 yrs old and

Secondary

MeasureTime frame
To study their associations with the current virological/clinical and therapeutic status, the duration of uncontrolled viremia (defined by treatment history), the virological, immunological (CD4+ numbers), and clinical status

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026