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

HIV Infection Clinical Trial

— CO19 COVERTE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269632
• Other study ID #: 2009-AO1219-48
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: December 27, 2018

Study information

• Verified date: July 2018
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: December 27, 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections
• Young Adult

Intervention

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

Locations

Country	Name	City	State
France	Hôpitaux (voir liste jointe)	De France

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

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