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

Long Term Evaluation of Young Adults Born to HIV-infected Mothers. A Cohort of Young Adults Infected With HIV Since Birth or During Childhood

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Young Adult
• Intervention / Treatment: Biological: blood sampling, specific biological exams and biobank and 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.

• Study Type: Interventional
• Enrollment (Actual): 469
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • De France, France
    • Hôpitaux (voir liste jointe)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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; clinical and therapeutic evaluation by physician; biological: blood sampling, specific biological exams and biobank; 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; clinical evaluation by physician; biological: blood sampling, specific biological exams and biobank; self administered questionnaires
Other: 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; clinical and therapeutic evaluation by physician; biological: blood sampling, specific biological exams and biobank; 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; clinical evaluation by physician; biological: blood sampling, specific biological exams and biobank; self administered questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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, Hôpital 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 Bicêtre; 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, Hôpital 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 27, 2018

Study Registration Dates

• First Submitted: September 17, 2010
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimate): January 4, 2011

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: comparison; teenagers to adult transition
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 2009-AO1219-48