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

NCT ID: NCT01269632

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

469 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2018-12-27

Brief Summary

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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

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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.

Conditions

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HIV Infection Young Adult

Keywords

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teenagers to adult transition comparison

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HIV infected

young adult infected by HIV

Group Type OTHER

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

Intervention Type 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 uninfected

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

Group Type OTHER

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

Intervention Type 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

Interventions

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

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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


* 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

Control Group


* Under protection(saving) of justice
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugues Aumaitre

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de Perpignan

Eric Froguel

Role: PRINCIPAL_INVESTIGATOR

Hopital de Lagny

Michèle Bentata

Role: PRINCIPAL_INVESTIGATOR

Hopital Avicenne

Philippe Genet

Role: PRINCIPAL_INVESTIGATOR

Hopital Argenteuil

Olivier Patey

Role: PRINCIPAL_INVESTIGATOR

CHIC Villeneuve St Georges

Laurence Gerard

Role: PRINCIPAL_INVESTIGATOR

St Louis Paris

Frédéric Lucht

Role: PRINCIPAL_INVESTIGATOR

St Etienne

Bruno Hoen

Role: PRINCIPAL_INVESTIGATOR

St Jacques Besançon

Jean Luc Schmit

Role: PRINCIPAL_INVESTIGATOR

Hôpital Nord Amiens

Claire Pintado

Role: PRINCIPAL_INVESTIGATOR

St Louis Paris

Cécile Goujard

Role: PRINCIPAL_INVESTIGATOR

Le Kremlin Bicetre

Thierry Allegre

Role: PRINCIPAL_INVESTIGATOR

CH Aix en Provence

Alain Lafeuillade

Role: PRINCIPAL_INVESTIGATOR

CHIC Toulon

Pierre De Truchis

Role: PRINCIPAL_INVESTIGATOR

Raymond Poincarré Garches

Vincent Jeantils

Role: PRINCIPAL_INVESTIGATOR

Jean Verdier Bondy

Claudine Duvivier

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur

Laurence Slama

Role: PRINCIPAL_INVESTIGATOR

Tenon Paris

Olivier Bouchaud

Role: PRINCIPAL_INVESTIGATOR

Hopital Avicenne Bobigny

Marie Karmochkine

Role: PRINCIPAL_INVESTIGATOR

Georges Pompidou Paris

Dominique Salmon Ceron

Role: PRINCIPAL_INVESTIGATOR

Cochin Paris

Emmanuel Mortier

Role: PRINCIPAL_INVESTIGATOR

Louis Mourier Colombes

Roland Tubiana

Role: PRINCIPAL_INVESTIGATOR

Pitié Salpétrière Paris

Pierre Marie Girard

Role: PRINCIPAL_INVESTIGATOR

St Antoine Paris

André Cabié

Role: PRINCIPAL_INVESTIGATOR

CHU Fort de France

Jean Marie Chennebault

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Philippe Morlat

Role: PRINCIPAL_INVESTIGATOR

St André Bordeaux

Pierre Weinbreck

Role: PRINCIPAL_INVESTIGATOR

Hôpital Dupuytren

Laurent Cotte

Role: PRINCIPAL_INVESTIGATOR

La Croix Rousse Lyon

Sophie Matheron

Role: PRINCIPAL_INVESTIGATOR

Bichat Paris

Véronique Reliquet

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu Nantes

Philippe Pérré

Role: PRINCIPAL_INVESTIGATOR

CHD Les Oudairies La Roche Sur Yon

Cédric Arvieux

Role: PRINCIPAL_INVESTIGATOR

Hopital Pontchaillou Rennes

Christine Cheneau

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Strasbourg

Martine Obadia

Role: PRINCIPAL_INVESTIGATOR

CH Purpan Toulouse

Renaud Verdon

Role: PRINCIPAL_INVESTIGATOR

CHU Cote de Nacre Caen

Christine Jacomet

Role: PRINCIPAL_INVESTIGATOR

Hopital Gabriel Montpied Clermont Ferrand

Lionel Piroth

Role: PRINCIPAL_INVESTIGATOR

CHU Hopital d'enfants Dijon

Antoine Chéret

Role: PRINCIPAL_INVESTIGATOR

CH TOURCOING

Yasmine Debab

Role: PRINCIPAL_INVESTIGATOR

CHU Charles Nicolle Rouen

Dominique Merrien

Role: PRINCIPAL_INVESTIGATOR

CH Compiègne

Patrick Mercié

Role: PRINCIPAL_INVESTIGATOR

CHU St André Bordeaux

Valérie Garrait

Role: PRINCIPAL_INVESTIGATOR

CHIC Créteil

Marie Aude Khuong

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Général St Denis

Geneviève Beck Wirth

Role: PRINCIPAL_INVESTIGATOR

CH Mulhouse

Stéphane Blanche

Role: PRINCIPAL_INVESTIGATOR

Necker Paris

Franck Boccara

Role: PRINCIPAL_INVESTIGATOR

St Antoine Paris

Claudine Barbuat

Role: PRINCIPAL_INVESTIGATOR

CHR Caremeau Nimes

Jean Paul Viard

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu Paris

Ghislaine Firtion

Role: PRINCIPAL_INVESTIGATOR

Cochin Paris

Albert Faye

Role: PRINCIPAL_INVESTIGATOR

Robert Debré Paris

Catherine Dollfus

Role: PRINCIPAL_INVESTIGATOR

Armand Trousseau Paris

Corinne Floch Tudal

Role: PRINCIPAL_INVESTIGATOR

Louis Mourier Colombes

Kamila Kebaili

Role: PRINCIPAL_INVESTIGATOR

Hopital de jour ISHOP Lyon

Joelle Tricoire

Role: PRINCIPAL_INVESTIGATOR

CHU Paule de Viguier Toulouse

Françoise Mazingue

Role: PRINCIPAL_INVESTIGATOR

CHR Jeanne de Flandres Lille

Pascal Bolot

Role: PRINCIPAL_INVESTIGATOR

CHG St Denis

Francois Bissuel

Role: PRINCIPAL_INVESTIGATOR

CH LC Fleming St Martin Guadeloupe

Anne Chace

Role: PRINCIPAL_INVESTIGATOR

CHIC Villeneuve St Georges

Narcisse Elenga

Role: PRINCIPAL_INVESTIGATOR

CHG Andrée Rosemon Cayenne

Natacha Entz Werle

Role: PRINCIPAL_INVESTIGATOR

Hautepierre Strasbourg

Thomas Girard

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu Paris

Martine Levine

Role: PRINCIPAL_INVESTIGATOR

Robert Debré Paris

Benoit Martha

Role: PRINCIPAL_INVESTIGATOR

CH Chalon sur Soane

Sandrine Anne Martha

Role: PRINCIPAL_INVESTIGATOR

Chalon sur Saone

Patrice Poubeau

Role: PRINCIPAL_INVESTIGATOR

CHR Réunion St Pierre

Jean Marc Treluyer

Role: PRINCIPAL_INVESTIGATOR

CIC Necker Paris

Louis Bernard

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bretonneau Tours

Michel Dupon

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pellegrin Bordeaux

David Zucman

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch Suresnes

Anne Simon

Role: PRINCIPAL_INVESTIGATOR

Pitié Salpétrière Paris

Isabellle Poizot Martin

Role: PRINCIPAL_INVESTIGATOR

Ste Marguerite Marseille

Thierry Prazuck

Role: PRINCIPAL_INVESTIGATOR

CHR Orléans

Eric Doré

Role: PRINCIPAL_INVESTIGATOR

CHU Estains Clermont Ferrand

Catherine Gaud

Role: PRINCIPAL_INVESTIGATOR

CHR Site Felix Guyon Bellepierre La Réunion

Locations

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Hôpitaux (voir liste jointe)

De France, , France

Site Status

Countries

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France

Related Links

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http://anrs.fr

Related Info

Other Identifiers

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2009-AO1219-48

Identifier Type: -

Identifier Source: org_study_id