Immunology of the Infection Perinatal

NCT01055873 | Completed

• 1 other identifier: 2006-AO142-49
• Study Type: observational
• Target: 93
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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

Interventions

A single blood sample (30 mL) BIOLOGICAL

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \- Not Being affiliated to the French national social security system

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Institut Pasteur: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• Hôpital Necker-Enfants Malades: collaborator

Related Publications (1)

• 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.

  PMID: 22427678 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  STUDY CHAIR

• Blanche PHD Stéphane

  Hopital Necker Enfants malades-Service immunologie hématologie pédiatrique -149 rue de Sèvres- 75015 PARIS 01 44 49 48 24

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 24, 2009
• First Posted: January 26, 2010
• Study Start: February 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 18, 2010

Record last verified: 2010-11