Clinical trial NCT01269632: Cohort of Young Adults Infected With HIV Since Birth or During Childhood
Official title: Long Term Evaluation of Young Adults Born to HIV-infected Mothers. A Cohort of Young Adults Infected With HIV Since Birth or During Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Young Adult
Keywords: teenagers to adult transition
comparison
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2011-01-04
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Methods: A national multicenter cohort of young adults, infected with HIV since birth or during childhood, including a common module and a physiopathological module (metabolic,, cardiovascular and immunological). A control group of HIV-uninfected young adults is included for comparison in the latter module. Patients aged between 18 and 25 years of age, whose HIV diagnosis was made before the age of 13 are eligible for ANRS CO19 COVERTE. This cohort is an extension of the EPF cohort (ANRS CO10), in which follow-up stops at the age 18, with an extension to adults with a HIV diagnosis established before the age of 13. Questionnaires are filled out by physicians once a year. Self-administered questionnaires are also carried out. Blood sampling and specific biological exams are collected and a biobank constituted. In the physiopathological module, specific exams are carried out at inclusion and after 3 years of follow-up: metabolic and immunological exams, OGTT, CT-scan and DXA-scan, and cardiovascular explorations (carotid intima-media thickness, pulse wave velocity ...). An estimated 400 enrolments during the first 3 years is expected in the common module and an estimated 200 HIV-infected subjects and 75 uninfected controls is expected in the physiopathological module.

Expected results: The follow-up of young adults in this cohort will bring new data on the long term efficacy of antiretroviral treatment and their adverse events, from the metabolic, cardiovascular and immunological, point of view, be they linked or not to HIV infection per se. This analysis will take into account the characteristics of this population, as compared to adults infected during adulthood: an early exposure to HIV and antiretroviral treatment, a different social context, difficulties in care, and a different exposure to risk factors for adverse events and complications. We will evaluate the impact of the transition to adulthood and of the transition from paediatrics to adult departments, on clinical prognosis, adherence, professional and schooling integration, sexuality, social life.

Eligibility criteria: Group of HIV Infection

Inclusion Criteria:

* 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

Exclusion Criteria (for physiopathological module only)

* Under protection(saving) of justice

Control Group

Inclusion Criteria:

* 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

Exclusion Criteria:

* Under protection(saving) of justice

Primary outcomes:
measure: Immuno virological and clinical prognosis: HIV RNA <50c/mL, CD4 cells count>500 cells/mL, vital status, CDC stage
timeFrame: at inclusion and annually up to 06 years follow-up
Secondary outcomes:
measure: Professional and schooling integration, social life:marital status, type of accommodation, education level, type and age at first employment
timeFrame: at inclusion and annually up to 6 years follow up
measure: sexuality, sexual risk behaviour: age at first intercourse, condom use at first, last sexual intercourse, and during last year, unplanned pregnancy, interruption of pregnancy
timeFrame: at inclusion and annually up to 6 year follow-up
measure: 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
timeFrame: at inclusion and after 3 years follow-up
measure: 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
timeFrame: at inclusion and after 3 years follow-up
Other outcomes:
Locations:
city: De France
country: France
facility: Hôpitaux (voir liste jointe)
Study officials:
affiliation: Centre hospitalier de Perpignan
name: Hugues Aumaitre
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital de Lagny
name: Eric Froguel
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Avicenne
name: Michèle Bentata
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Argenteuil
name: Philippe Genet
role: PRINCIPAL_INVESTIGATOR
affiliation: CHIC Villeneuve St Georges
name: Olivier Patey
role: PRINCIPAL_INVESTIGATOR
affiliation: St Louis Paris
name: Laurence Gerard
role: PRINCIPAL_INVESTIGATOR
affiliation: St Etienne
name: Frédéric Lucht
role: PRINCIPAL_INVESTIGATOR
affiliation: St Jacques Besançon
name: Bruno Hoen
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Nord Amiens
name: Jean Luc Schmit
role: PRINCIPAL_INVESTIGATOR
affiliation: St Louis Paris
name: Claire Pintado
role: PRINCIPAL_INVESTIGATOR
affiliation: Le Kremlin Bicetre
name: Cécile Goujard
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Aix en Provence
name: Thierry Allegre
role: PRINCIPAL_INVESTIGATOR
affiliation: CHIC Toulon
name: Alain Lafeuillade
role: PRINCIPAL_INVESTIGATOR
affiliation: Raymond Poincarré Garches
name: Pierre De Truchis
role: PRINCIPAL_INVESTIGATOR
affiliation: Jean Verdier Bondy
name: Vincent Jeantils
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Pasteur
name: Claudine Duvivier
role: PRINCIPAL_INVESTIGATOR
affiliation: Tenon Paris
name: Laurence Slama
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Avicenne Bobigny
name: Olivier Bouchaud
role: PRINCIPAL_INVESTIGATOR
affiliation: Georges Pompidou Paris
name: Marie Karmochkine
role: PRINCIPAL_INVESTIGATOR
affiliation: Cochin Paris
name: Dominique Salmon Ceron
role: PRINCIPAL_INVESTIGATOR
affiliation: Louis Mourier Colombes
name: Emmanuel Mortier
role: PRINCIPAL_INVESTIGATOR
affiliation: Pitié Salpétrière Paris
name: Roland Tubiana
role: PRINCIPAL_INVESTIGATOR
affiliation: St Antoine Paris
name: Pierre Marie Girard
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Fort de France
name: André Cabié
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Jean Marie Chennebault
role: PRINCIPAL_INVESTIGATOR
affiliation: St André Bordeaux
name: Philippe Morlat
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Dupuytren
name: Pierre Weinbreck
role: PRINCIPAL_INVESTIGATOR
affiliation: La Croix Rousse Lyon
name: Laurent Cotte
role: PRINCIPAL_INVESTIGATOR
affiliation: Bichat Paris
name: Sophie Matheron
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu Nantes
name: Véronique Reliquet
role: PRINCIPAL_INVESTIGATOR
affiliation: CHD Les Oudairies La Roche Sur Yon
name: Philippe Pérré
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Pontchaillou Rennes
name: Cédric Arvieux
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Strasbourg
name: Christine Cheneau
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Purpan Toulouse
name: Martine Obadia
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Cote de Nacre Caen
name: Renaud Verdon
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Gabriel Montpied Clermont Ferrand
name: Christine Jacomet
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Hopital d'enfants Dijon
name: Lionel Piroth
role: PRINCIPAL_INVESTIGATOR
affiliation: CH TOURCOING
name: Antoine Chéret
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Charles Nicolle Rouen
name: Yasmine Debab
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Compiègne
name: Dominique Merrien
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU St André Bordeaux
name: Patrick Mercié
role: PRINCIPAL_INVESTIGATOR
affiliation: CHIC Créteil
name: Valérie Garrait
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Général St Denis
name: Marie Aude Khuong
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Mulhouse
name: Geneviève Beck Wirth
role: PRINCIPAL_INVESTIGATOR
affiliation: Necker Paris
name: Stéphane Blanche
role: PRINCIPAL_INVESTIGATOR
affiliation: St Antoine Paris
name: Franck Boccara
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Caremeau Nimes
name: Claudine Barbuat
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu Paris
name: Jean Paul Viard
role: PRINCIPAL_INVESTIGATOR
affiliation: Cochin Paris
name: Ghislaine Firtion
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Debré Paris
name: Albert Faye
role: PRINCIPAL_INVESTIGATOR
affiliation: Armand Trousseau Paris
name: Catherine Dollfus
role: PRINCIPAL_INVESTIGATOR
affiliation: Louis Mourier Colombes
name: Corinne Floch Tudal
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital de jour ISHOP Lyon
name: Kamila Kebaili
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Paule de Viguier Toulouse
name: Joelle Tricoire
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Jeanne de Flandres Lille
name: Françoise Mazingue
role: PRINCIPAL_INVESTIGATOR
affiliation: CHG St Denis
name: Pascal Bolot
role: PRINCIPAL_INVESTIGATOR
affiliation: CH LC Fleming St Martin Guadeloupe
name: Francois Bissuel
role: PRINCIPAL_INVESTIGATOR
affiliation: CHIC Villeneuve St Georges
name: Anne Chace
role: PRINCIPAL_INVESTIGATOR
affiliation: CHG Andrée Rosemon Cayenne
name: Narcisse Elenga
role: PRINCIPAL_INVESTIGATOR
affiliation: Hautepierre Strasbourg
name: Natacha Entz Werle
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu Paris
name: Thomas Girard
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Debré Paris
name: Martine Levine
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Chalon sur Soane
name: Benoit Martha
role: PRINCIPAL_INVESTIGATOR
affiliation: Chalon sur Saone
name: Sandrine Anne Martha
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Réunion St Pierre
name: Patrice Poubeau
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC Necker Paris
name: Jean Marc Treluyer
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bretonneau Tours
name: Louis Bernard
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Pellegrin Bordeaux
name: Michel Dupon
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Foch Suresnes
name: David Zucman
role: PRINCIPAL_INVESTIGATOR
affiliation: Pitié Salpétrière Paris
name: Anne Simon
role: PRINCIPAL_INVESTIGATOR
affiliation: Ste Marguerite Marseille
name: Isabellle Poizot Martin
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Orléans
name: Thierry Prazuck
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Estains Clermont Ferrand
name: Eric Doré
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Site Felix Guyon Bellepierre La Réunion
name: Catherine Gaud
role: PRINCIPAL_INVESTIGATOR
References: