Trial record 20 of 36 for:    " September 15, 2010":" October 15, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Cohort of Young Adults Infected With HIV Since Birth or During Childhood (CO19 COVERTE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01269632
First received: September 17, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
HIV Infection
Young Adult
Biological: blood sampling, specific biological exams and biobank and self administered questionnaires

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Immuno virological and clinical prognosis: HIV RNA <50c/mL, CD4 cells count>500 cells/mL, vital status, CDC stage [ Time Frame: at inclusion and annually up to 06 years follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Professional and schooling integration, social life:marital status, type of accommodation, education level, type and age at first employment [ Time Frame: at inclusion and annually up to 6 years follow up ] [ Designated as safety issue: No ]
  • sexuality, sexual risk behaviour: age at first intercourse, condom use at first, last sexual intercourse, and during last year, unplanned pregnancy, interruption of pregnancy [ Time Frame: at inclusion and annually up to 6 year follow-up ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at inclusion and after 3 years follow-up ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at inclusion and after 3 years follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HIV infected
young adult infected by HIV
Biological: 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
HIV uninfected
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

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

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

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269632

Contacts
Contact: Mélanie Thoumine 01 49 59 53 23 melanie.thoumine@inserm.fr
Contact: Josiane Warszawski 01 49 59 53 05 josiane.warszawski@inserm.fr

Locations
France
Hôpitaux (voir liste jointe) Recruiting
de France, France
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Hugues Aumaitre CH 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 CHU Dupuytren (Limoges)
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
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier: NCT01269632     History of Changes
Other Study ID Numbers: 2009-AO1219-48
Study First Received: September 17, 2010
Last Updated: July 22, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
teenagers to adult transition
comparison

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 26, 2014