Immunology of the Infection Perinatal (EP38)

November 17, 2010 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

93

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Exclusion criteria

- Not Being affiliated to the French national social security system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Institut Pasteur
University of Paris 5 - Rene Descartes
Hôpital Necker-Enfants Malades

Investigators

  • Study Chair: Warszawski MD Josiane, Methodologist, INSERM U 822, Hôpital de Bicêtre, portes 10 à 15, 82 rue du Général Leclerc, 94276 Le Kremlin-Bicêtre Cedex warszaws@vjf.inserm.fr ; Tel : 01 45 21 22 86
  • Principal Investigator: Blanche PHD Stéphane, Hopital Necker Enfants malades-Service immunologie hématologie pédiatrique -149 rue de Sèvres- 75015 PARIS 01 44 49 48 24

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 24, 2009

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

November 18, 2010

Last Update Submitted That Met QC Criteria

November 17, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-AO142-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on A single blood sample (30 mL)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe