Immunology of the Infection Perinatal (EP38)

This study has been completed.
Sponsor:
Collaborators:
Institut Pasteur
University of Paris 5 - Rene Descartes
Hôpital Necker-Enfants Malades
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT01055873
First received: December 24, 2009
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
HIV Infections
Biological: A single blood sample (30 mL)

Study Type: Observational
Official Title: Immunology of the Infection Perinatal

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • To describe the immune and virological status of perinatally infected patients that are above 15 yrs old and [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

..


Enrollment: 93
Study Start Date: February 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: A 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
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055873

Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
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
  More Information

Additional Information:
No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lucie Marchand/Project manager, French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT01055873     History of Changes
Other Study ID Numbers: 2006-AO142-49
Study First Received: December 24, 2009
Last Updated: November 17, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
immune status
adolescents or young adults infected
impact of viral replication

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 20, 2014