Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT01269632
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2010-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cohort of Young Adults Infected With HIV Since Birth or During Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D018070', 'term': 'Biological Specimen Banks'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 469}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2010-09-17', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['teenagers to adult transition', 'comparison'], 'conditions': ['HIV Infection', 'Young Adult']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://anrs.fr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nObjectives: 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.', 'detailedDescription': '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.\n\nExpected 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Group of HIV Infection\n\nInclusion Criteria:\n\n* Age ≥ 18 and \\< 25 years\n* Able to give written consent\n* Covered by French Social Security\n* diagnosis of HIV-1 et/ou-2 documented before age 13\n\nExclusion Criteria (for physiopathological module only)\n\n* Under protection(saving) of justice\n\nControl Group\n\nInclusion Criteria:\n\n* Age ≥ 18 and ≤ 25 years\n* Able to give written consent\n* Covered by French Social Security\n* With a brother or sister, cousin, father or mother HIV infected, inbred or adopted\n* With a negative serology for HIV infection, HBV, HCV\n* Without diabetes mellitus\n* able to go to Clinical Investigation Center of Necker and to Hospital St. Antoine for the recruitment and monitoring\n\nExclusion Criteria:\n\n* Under protection(saving) of justice'}, 'identificationModule': {'nctId': 'NCT01269632', 'acronym': 'CO19 COVERTE', 'briefTitle': 'Cohort of Young Adults Infected With HIV Since Birth or During Childhood', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Long Term Evaluation of Young Adults Born to HIV-infected Mothers. A Cohort of Young Adults Infected With HIV Since Birth or During Childhood', 'orgStudyIdInfo': {'id': '2009-AO1219-48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HIV infected', 'description': 'young adult infected by HIV', 'interventionNames': ['Biological: blood sampling, specific biological exams and biobank and self administered questionnaires']}, {'type': 'OTHER', 'label': 'HIV uninfected', 'description': 'a control group of HIV uninfected young adult will be included for comparison in physiopathological module (metabolic, cardiovascular, and immunological)', 'interventionNames': ['Biological: blood sampling, specific biological exams and biobank and self administered questionnaires']}], 'interventions': [{'name': 'blood sampling, specific biological exams and biobank and self administered questionnaires', 'type': 'BIOLOGICAL', 'description': 'HIV INFECTION at inclusion and annually up to 06 years follow-up\n\n1. clinical and therapeutic evaluation by physician\n2. biological: blood sampling, specific biological exams and biobank\n3. self administered questionnaires\n\nIn 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)\n\nHIV UNINFECTED at inclusion and after 3 years follow up\n\n1. clinical evaluation by physician\n2. biological: blood sampling, specific biological exams and biobank\n3. self administered questionnaires', 'armGroupLabels': ['HIV infected', 'HIV uninfected']}]}, 'contactsLocationsModule': {'locations': [{'city': 'De France', 'country': 'France', 'facility': 'Hôpitaux (voir liste jointe)'}], 'overallOfficials': [{'name': 'Hugues Aumaitre', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre hospitalier de Perpignan'}, {'name': 'Eric Froguel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital de Lagny'}, {'name': 'Michèle Bentata', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Avicenne'}, {'name': 'Philippe Genet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Argenteuil'}, {'name': 'Olivier Patey', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHIC Villeneuve St Georges'}, {'name': 'Laurence Gerard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Louis Paris'}, {'name': 'Frédéric Lucht', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Etienne'}, {'name': 'Bruno Hoen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Jacques Besançon'}, {'name': 'Jean Luc Schmit', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Nord Amiens'}, {'name': 'Claire Pintado', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Louis Paris'}, {'name': 'Cécile Goujard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Le Kremlin Bicetre'}, {'name': 'Thierry Allegre', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Aix en Provence'}, {'name': 'Alain Lafeuillade', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHIC Toulon'}, {'name': 'Pierre De Truchis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Raymond Poincarré Garches'}, {'name': 'Vincent Jeantils', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jean Verdier Bondy'}, {'name': 'Claudine Duvivier', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Pasteur'}, {'name': 'Laurence Slama', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tenon Paris'}, {'name': 'Olivier Bouchaud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Avicenne Bobigny'}, {'name': 'Marie Karmochkine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georges Pompidou Paris'}, {'name': 'Dominique Salmon Ceron', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cochin Paris'}, {'name': 'Emmanuel Mortier', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louis Mourier Colombes'}, {'name': 'Roland Tubiana', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pitié Salpétrière Paris'}, {'name': 'Pierre Marie Girard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Antoine Paris'}, {'name': 'André Cabié', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Fort de France'}, {'name': 'Jean Marie Chennebault', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}, {'name': 'Philippe Morlat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St André Bordeaux'}, {'name': 'Pierre Weinbreck', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Dupuytren'}, {'name': 'Laurent Cotte', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'La Croix Rousse Lyon'}, {'name': 'Sophie Matheron', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bichat Paris'}, {'name': 'Véronique Reliquet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hotel Dieu Nantes'}, {'name': 'Philippe Pérré', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHD Les Oudairies La Roche Sur Yon'}, {'name': 'Cédric Arvieux', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Pontchaillou Rennes'}, {'name': 'Christine Cheneau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Strasbourg'}, {'name': 'Martine Obadia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Purpan Toulouse'}, {'name': 'Renaud Verdon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Cote de Nacre Caen'}, {'name': 'Christine Jacomet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Gabriel Montpied Clermont Ferrand'}, {'name': 'Lionel Piroth', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CHU Hopital d'enfants Dijon"}, {'name': 'Antoine Chéret', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH TOURCOING'}, {'name': 'Yasmine Debab', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Charles Nicolle Rouen'}, {'name': 'Dominique Merrien', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Compiègne'}, {'name': 'Patrick Mercié', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU St André Bordeaux'}, {'name': 'Valérie Garrait', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHIC Créteil'}, {'name': 'Marie Aude Khuong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Général St Denis'}, {'name': 'Geneviève Beck Wirth', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Mulhouse'}, {'name': 'Stéphane Blanche', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necker Paris'}, {'name': 'Franck Boccara', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Antoine Paris'}, {'name': 'Claudine Barbuat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Caremeau Nimes'}, {'name': 'Jean Paul Viard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hotel Dieu Paris'}, {'name': 'Ghislaine Firtion', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cochin Paris'}, {'name': 'Albert Faye', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert Debré Paris'}, {'name': 'Catherine Dollfus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Armand Trousseau Paris'}, {'name': 'Corinne Floch Tudal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louis Mourier Colombes'}, {'name': 'Kamila Kebaili', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital de jour ISHOP Lyon'}, {'name': 'Joelle Tricoire', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Paule de Viguier Toulouse'}, {'name': 'Françoise Mazingue', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Jeanne de Flandres Lille'}, {'name': 'Pascal Bolot', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHG St Denis'}, {'name': 'Francois Bissuel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH LC Fleming St Martin Guadeloupe'}, {'name': 'Anne Chace', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHIC Villeneuve St Georges'}, {'name': 'Narcisse Elenga', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHG Andrée Rosemon Cayenne'}, {'name': 'Natacha Entz Werle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hautepierre Strasbourg'}, {'name': 'Thomas Girard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hotel Dieu Paris'}, {'name': 'Martine Levine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert Debré Paris'}, {'name': 'Benoit Martha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Chalon sur Soane'}, {'name': 'Sandrine Anne Martha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chalon sur Saone'}, {'name': 'Patrice Poubeau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Réunion St Pierre'}, {'name': 'Jean Marc Treluyer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CIC Necker Paris'}, {'name': 'Louis Bernard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Bretonneau Tours'}, {'name': 'Michel Dupon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Pellegrin Bordeaux'}, {'name': 'David Zucman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Foch Suresnes'}, {'name': 'Anne Simon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pitié Salpétrière Paris'}, {'name': 'Isabellle Poizot Martin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ste Marguerite Marseille'}, {'name': 'Thierry Prazuck', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Orléans'}, {'name': 'Eric Doré', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Estains Clermont Ferrand'}, {'name': 'Catherine Gaud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Site Felix Guyon Bellepierre La Réunion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}