Immunology of the Infection Perinatal (EP38)
Primary Purpose
HIV Infections
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
A single blood sample (30 mL)
Sponsored by
About this trial
This is an observational trial for HIV Infections focused on measuring immune status, adolescents or young adults infected, impact of viral replication
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
To describe the immune and virological status of perinatally infected patients that are above 15 yrs old and
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
Full Information
NCT ID
NCT01055873
First Posted
December 24, 2009
Last Updated
November 17, 2010
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Institut Pasteur, University of Paris 5 - Rene Descartes, Hôpital Necker-Enfants Malades
1. Study Identification
Unique Protocol Identification Number
NCT01055873
Brief Title
Immunology of the Infection Perinatal
Acronym
EP38
Official Title
Immunology of the Infection Perinatal
Study Type
Observational
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Institut Pasteur, University of Paris 5 - Rene Descartes, Hôpital Necker-Enfants Malades
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
disease progression independently of CD4+ T cell levels;
accelerated senescence of the immune system;
destruction of organs involved in the restoration of major immune cell populations.
The aims of the study are:
to describe the immune and virological status of perinatally infected patients that are above 15 yrs old and
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
immune status, adolescents or young adults infected, impact of viral replication
7. Study Design
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
A single blood sample (30 mL)
Intervention Description
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
Primary Outcome Measure Information:
Title
To describe the immune and virological status of perinatally infected patients that are above 15 yrs old and
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
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
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warszawski MD Josiane, Methodologist
Organizational Affiliation
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
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Blanche PHD Stéphane
Organizational Affiliation
Hopital Necker Enfants malades-Service immunologie hématologie pédiatrique -149 rue de Sèvres- 75015 PARIS 01 44 49 48 24
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22427678
Citation
Avettand-Fenoel V, Blanche S, Le Chenadec J, Scott-Algara D, Dollfus C, Viard JP, Bouallag N, Benmebarek Y, Riviere Y, Warszawski J, Rouzioux C, Buseyne F. Relationships between HIV disease history and blood HIV-1 DNA load in perinatally infected adolescents and young adults: the ANRS-EP38-IMMIP study. J Infect Dis. 2012 May 15;205(10):1520-8. doi: 10.1093/infdis/jis233. Epub 2012 Mar 15.
Results Reference
derived
Links:
URL
http://www.anrs.fr
Description
Related Info
Learn more about this trial
Immunology of the Infection Perinatal
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