HIV InfectionCO19 COVERTENCT01269632
Cohort of Young Adults Infected With HIV Since Birth or During Childhood
A study testing blood sampling, specific biological exams and biobank and self administered questionnaires in people with HIV Infection and Young Adult, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Young Adult
- What is being tested?
- blood sampling, specific biological exams and biobank and self administered questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to 27 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Under protection(saving) of justice
- Control Group
- Under protection(saving) of justice
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- HIV Infection, Young Adult
- Being tested
- blood sampling, specific biological exams and biobank and self administered questionnaires
- Keywords
- teenagers to adult transition, comparison
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling, specific biological exams and biobank and self administered questionnairesBiological
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
| Study group | Role | What they receive |
|---|---|---|
| HIV infected | Other | young adult infected by HIV Receives: Biological: blood sampling, specific biological exams and biobank and self administered questionnaires |
| HIV uninfected | Other | a control group of HIV uninfected young adult will be included for comparison in physiopathological module (metabolic, cardiovascular, and immunological) Receives: Biological: blood sampling, specific biological exams and biobank and self administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immuno virological and clinical prognosis: HIV RNA <50c/mL, CD4 cells count>500 cells/mL, vital status, CDC stage
Measured: at inclusion and annually up to 06 years follow-up
Secondary outcomes (4)
Professional and schooling integration, social life:marital status, type of accommodation, education level, type and age at first employment
Measured: 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
Measured: 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
Measured: 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
Measured: at inclusion and after 3 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJun 2010
- Primary completionDec 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hugues Aumaitre, Principal investigator, Perpignan Hospital CenterEric Froguel, Principal investigator, Hopital de LagnyMichèle Bentata, Principal investigator, Hopital AvicennePhilippe Genet, Principal investigator, Hopital ArgenteuilOlivier Patey, Principal investigator, CHIC Villeneuve St GeorgesLaurence Gerard, Principal investigator, St Louis ParisFrédéric Lucht, Principal investigator, St EtienneBruno Hoen, Principal investigator, St Jacques Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269632
- Sponsor's protocol ID
- 2009-AO1219-48
- Acronym
- CO19 COVERTE
- Status last verified
- Jul 2018
- First submitted
- 17 Sep 2010
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01269632
- Acronym / sponsor ID
- CO19 COVERTE / 2009-AO1219-48
- Conditions
- HIV Infection, Young Adult
- Keywords
- teenagers to adult transition, comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Jun 2010
- Primary completion
- Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV infected | Other | Biological: blood sampling, specific biological exams and biobank and self administered questionnairesyoung adult infected by HIV |
| HIV uninfected | Other | Biological: blood sampling, specific biological exams and biobank and self administered questionnairesa control group of HIV uninfected young adult will be included for comparison in physiopathological module (metabolic, cardiovascular, and immunological) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- Under protection(saving) of justice
- Control Group
- Under protection(saving) of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling, specific biological exams and biobank and self administered questionnairesHIV 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 | Biological | HIV infected, HIV uninfected |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugues Aumaitre principal investigator
Perpignan Hospital Center
Eric Froguel principal investigator
Hopital de Lagny
Michèle Bentata principal investigator
Hopital Avicenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling, specific biological exams and biobank and self administered questionnaires in people with HIV Infection and Young Adult, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.