Cohort of Young Adults Infected With HIV Since Birth or During Childhood

NCT01269632 | Completed

• 1 other identifier: 2009-AO1219-48
• Study Type: interventional
• Target: 469
• Locations: 1 country
• Sites: 1

Brief Summary

Background: With the improvement of the prognosis for HIV-infected infants, thanks to the availability of antiretroviral therapies, young adults infected with HIV since birth are becoming an emerging group among the HIV-infected population. Morbidity, mortality and immunovirological evolution in these young adults need to be studied in a large population and compared to patients infected with HIV later in adulthood or to the general population in terms of mortality. Moreover, the study of accelerated or premature ageing, linked to HIV and/or antiretroviral therapy, is particularly interesting in this population. Objectives: To study the transition to adulthood and the further evolution of HIV-1 or -2 perinatally infected young adults: 1) To study the teenager to adult transition in terms of clinical and immunovirological status, schooling and professional integration, sexuality and reproductive life, transition from paediatrics to adult departments; 2) To study prognosis, morbidity and mortality according to age, infection stage at the time of antiretroviral initiation and therapeutic history; 3) To study the incidence and expression of adverse events and the potential link to antiretroviral therapies; 4) To study the markers of a potential premature ageing, from the metabolic, cardiovascular and immunological points of view.

Conditions

HIV Infection; Young Adult

Keywords

teenagers to adult transition; comparison

Outcome Measures

Primary Outcomes (1)

• Immuno virological and clinical prognosis: HIV RNA <50c/mL, CD4 cells count>500 cells/mL, vital status, CDC stage

  at inclusion and annually up to 06 years follow-up

Secondary Outcomes (4)

• Professional and schooling integration, social life:marital status, type of accommodation, education level, type and age at first employment

  at inclusion and annually up to 6 years follow up

• sexuality, sexual risk behaviour: age at first intercourse, condom use at first, last sexual intercourse, and during last year, unplanned pregnancy, interruption of pregnancy

  at inclusion and annually up to 6 year follow-up

• metabolic and cardiovascular abnormalities: abnormalities in glucose tolerance and insulino-resistance, dyslipidemia, lipodystrophy, adipocyte dysfunction, atherosclerosis,dysfunction, median of intima media thickness and pulse wave velocity

  at inclusion and after 3 years follow-up

• Lymphocyte phenotype and functional capacity of T lymphocyte: description of dysfunctional CMV-specific T cell, T cell responses measured at inclusion, and their evolution during follow-up

  at inclusion and after 3 years follow-up

Study Arms (2)

HIV infected

OTHER

young adult infected by HIV

Biological: blood sampling, specific biological exams and biobank and self administered questionnaires

HIV uninfected

OTHER

a control group of HIV uninfected young adult will be included for comparison in physiopathological module (metabolic, cardiovascular, and immunological)

Biological: blood sampling, specific biological exams and biobank and self administered questionnaires

Interventions

blood sampling, specific biological exams and biobank and self administered questionnaires BIOLOGICAL

HIV INFECTION at inclusion and annually up to 06 years follow-up 1. clinical and therapeutic evaluation by physician 2. biological: blood sampling, specific biological exams and biobank 3. self administered questionnaires In the physiopathological module: at inclusion and after 3 years follow up: OGTT, CT Scan, Dexa Scan, cardiovascular explorations (carotid intima media thickness, pulse wave velocity, transthoracic echocardiography) HIV UNINFECTED at inclusion and after 3 years follow up 1. clinical evaluation by physician 2. biological: blood sampling, specific biological exams and biobank 3. self administered questionnaires

HIV infected; HIV uninfected

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 and \< 25 years
• Able to give written consent
• Covered by French Social Security
• diagnosis of HIV-1 et/ou-2 documented before age 13

You may not qualify if:

• Under protection(saving) of justice
• Control Group
• Age ≥ 18 and ≤ 25 years
• Able to give written consent
• Covered by French Social Security
• With a brother or sister, cousin, father or mother HIV infected, inbred or adopted
• With a negative serology for HIV infection, HBV, HCV
• Without diabetes mellitus
• able to go to Clinical Investigation Center of Necker and to Hospital St. Antoine for the recruitment and monitoring
• Under protection(saving) of justice

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Hôpitaux (voir liste jointe)

De France, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection; Biological Specimen Banks

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Hugues Aumaitre

  Centre hospitalier de Perpignan

  PRINCIPAL INVESTIGATOR

• Eric Froguel

  Hopital de Lagny

  PRINCIPAL INVESTIGATOR

• Michèle Bentata

  Hopital Avicenne

  PRINCIPAL INVESTIGATOR

• Philippe Genet

  Hopital Argenteuil

  PRINCIPAL INVESTIGATOR

• Olivier Patey

  CHIC Villeneuve St Georges

  PRINCIPAL INVESTIGATOR

• Laurence Gerard

  St Louis Paris

  PRINCIPAL INVESTIGATOR

• Frédéric Lucht

  St Etienne

  PRINCIPAL INVESTIGATOR

• Bruno Hoen

  St Jacques Besançon

  PRINCIPAL INVESTIGATOR

• Jean Luc Schmit

  Hôpital Nord Amiens

  PRINCIPAL INVESTIGATOR

• Claire Pintado

  St Louis Paris

  PRINCIPAL INVESTIGATOR

• Cécile Goujard

  Le Kremlin Bicetre

  PRINCIPAL INVESTIGATOR

• Thierry Allegre

  CH Aix en Provence

  PRINCIPAL INVESTIGATOR

• Alain Lafeuillade

  CHIC Toulon

  PRINCIPAL INVESTIGATOR

• Pierre De Truchis

  Raymond Poincarré Garches

  PRINCIPAL INVESTIGATOR

• Vincent Jeantils

  Jean Verdier Bondy

  PRINCIPAL INVESTIGATOR

• Claudine Duvivier

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

• Laurence Slama

  Tenon Paris

  PRINCIPAL INVESTIGATOR

• Olivier Bouchaud

  Hopital Avicenne Bobigny

  PRINCIPAL INVESTIGATOR

• Marie Karmochkine

  Georges Pompidou Paris

  PRINCIPAL INVESTIGATOR

• Dominique Salmon Ceron

  Cochin Paris

  PRINCIPAL INVESTIGATOR

• Emmanuel Mortier

  Louis Mourier Colombes

  PRINCIPAL INVESTIGATOR

• Roland Tubiana

  Pitié Salpétrière Paris

  PRINCIPAL INVESTIGATOR

• Pierre Marie Girard

  St Antoine Paris

  PRINCIPAL INVESTIGATOR

• André Cabié

  CHU Fort de France

  PRINCIPAL INVESTIGATOR

• Jean Marie Chennebault

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

• Philippe Morlat

  St André Bordeaux

  PRINCIPAL INVESTIGATOR

• Pierre Weinbreck

  Hôpital Dupuytren

  PRINCIPAL INVESTIGATOR

• Laurent Cotte

  La Croix Rousse Lyon

  PRINCIPAL INVESTIGATOR

• Sophie Matheron

  Bichat Paris

  PRINCIPAL INVESTIGATOR

• Véronique Reliquet

  Hotel Dieu Nantes

  PRINCIPAL INVESTIGATOR

• Philippe Pérré

  CHD Les Oudairies La Roche Sur Yon

  PRINCIPAL INVESTIGATOR

• Cédric Arvieux

  Hopital Pontchaillou Rennes

  PRINCIPAL INVESTIGATOR

• Christine Cheneau

  Centre Hospitalier Strasbourg

  PRINCIPAL INVESTIGATOR

• Martine Obadia

  CH Purpan Toulouse

  PRINCIPAL INVESTIGATOR

• Renaud Verdon

  CHU Cote de Nacre Caen

  PRINCIPAL INVESTIGATOR

• Christine Jacomet

  Hopital Gabriel Montpied Clermont Ferrand

  PRINCIPAL INVESTIGATOR

• Lionel Piroth

  CHU Hopital d'enfants Dijon

  PRINCIPAL INVESTIGATOR

• Antoine Chéret

  CH TOURCOING

  PRINCIPAL INVESTIGATOR

• Yasmine Debab

  CHU Charles Nicolle Rouen

  PRINCIPAL INVESTIGATOR

• Dominique Merrien

  CH Compiègne

  PRINCIPAL INVESTIGATOR

• Patrick Mercié

  CHU St André Bordeaux

  PRINCIPAL INVESTIGATOR

• Valérie Garrait

  CHIC Créteil

  PRINCIPAL INVESTIGATOR

• Marie Aude Khuong

  Centre Hospitalier Général St Denis

  PRINCIPAL INVESTIGATOR

• Geneviève Beck Wirth

  CH Mulhouse

  PRINCIPAL INVESTIGATOR

• Stéphane Blanche

  Necker Paris

  PRINCIPAL INVESTIGATOR

• Franck Boccara

  St Antoine Paris

  PRINCIPAL INVESTIGATOR

• Claudine Barbuat

  CHR Caremeau Nimes

  PRINCIPAL INVESTIGATOR

• Jean Paul Viard

  Hotel Dieu Paris

  PRINCIPAL INVESTIGATOR

• Ghislaine Firtion

  Cochin Paris

  PRINCIPAL INVESTIGATOR

• Albert Faye

  Robert Debré Paris

  PRINCIPAL INVESTIGATOR

• Catherine Dollfus

  Armand Trousseau Paris

  PRINCIPAL INVESTIGATOR

• Corinne Floch Tudal

  Louis Mourier Colombes

  PRINCIPAL INVESTIGATOR

• Kamila Kebaili

  Hopital de jour ISHOP Lyon

  PRINCIPAL INVESTIGATOR

• Joelle Tricoire

  CHU Paule de Viguier Toulouse

  PRINCIPAL INVESTIGATOR

• Françoise Mazingue

  CHR Jeanne de Flandres Lille

  PRINCIPAL INVESTIGATOR

• Pascal Bolot

  CHG St Denis

  PRINCIPAL INVESTIGATOR

• Francois Bissuel

  CH LC Fleming St Martin Guadeloupe

  PRINCIPAL INVESTIGATOR

• Anne Chace

  CHIC Villeneuve St Georges

  PRINCIPAL INVESTIGATOR

• Narcisse Elenga

  CHG Andrée Rosemon Cayenne

  PRINCIPAL INVESTIGATOR

• Natacha Entz Werle

  Hautepierre Strasbourg

  PRINCIPAL INVESTIGATOR

• Thomas Girard

  Hotel Dieu Paris

  PRINCIPAL INVESTIGATOR

• Martine Levine

  Robert Debré Paris

  PRINCIPAL INVESTIGATOR

• Benoit Martha

  CH Chalon sur Soane

  PRINCIPAL INVESTIGATOR

• Sandrine Anne Martha

  Chalon sur Saone

  PRINCIPAL INVESTIGATOR

• Patrice Poubeau

  CHR Réunion St Pierre

  PRINCIPAL INVESTIGATOR

• Jean Marc Treluyer

  CIC Necker Paris

  PRINCIPAL INVESTIGATOR

• Louis Bernard

  Hôpital Bretonneau Tours

  PRINCIPAL INVESTIGATOR

• Michel Dupon

  Hôpital Pellegrin Bordeaux

  PRINCIPAL INVESTIGATOR

• David Zucman

  Hôpital Foch Suresnes

  PRINCIPAL INVESTIGATOR

• Anne Simon

  Pitié Salpétrière Paris

  PRINCIPAL INVESTIGATOR

• Isabellle Poizot Martin

  Ste Marguerite Marseille

  PRINCIPAL INVESTIGATOR

• Thierry Prazuck

  CHR Orléans

  PRINCIPAL INVESTIGATOR

• Eric Doré

  CHU Estains Clermont Ferrand

  PRINCIPAL INVESTIGATOR

• Catherine Gaud

  CHR Site Felix Guyon Bellepierre La Réunion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: January 4, 2011
• Study Start: June 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 27, 2018
• Last Updated: December 7, 2020

Record last verified: 2018-07

Locations

FR (1)