HIV InfectionsEP38NCT01055873
Immunology of the Infection Perinatal
An observational study of HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis.
Trial summary
ANRS-EP38-IMMIP is a non interventional study. A single blood sample (30 mL) was drawn during a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood. Cells and plasma were stored and kept frozen for additional biological evaluations. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- A single blood sample (30 mL)
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Feb 2009
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients are included in the French perinatal cohort (ANRS CO-10), or have been followed since before 1996 in the same clinical sites as patients who belong to ANRS CO-10. In the ANRS CO-10 cohort, all patients are prospectively followed from birth
Who may be able to join
- Being included in the ANRS CO-10 cohort, or being followed in the same sites as such patients since before 1996
- Being followed in the Paris area
- HIV-1 infected through the perinatal route, and not HIV-2 co-infected
- No therapeutic changes for at least 6 months; single molecule change without modification of viral load is tolerated.
- Informed consent signed by the patients and by their legal guardians for those younger than 18.
- Being affiliated to the Exclusion criteria French national social security system
Who cannot join
- Not Being affiliated to the French national social security system
About this study
ANRS-EP38-IMMIP is a non interventional study. A single blood sample (30 mL) was drawn during a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood. Cells and plasma were stored and kept frozen for additional biological evaluations.
Patients are included in the French perinatal cohort (ANRS CO-10), or have been followed since before 1996 in the same clinical sites as patients who belong to ANRS CO-10. In the ANRS CO-10 cohort, all patients are prospectively followed from birth.
Read the detailed description
Purpose:
Efficient anti-retroviral treatments lead to a significantly increased life expectancy. Children with perinatal infection are now reaching adulthood. The deleterious impact of viral replication during ontogenesis of the immune system, and the high thymic activity during the early years of life, preclude an extrapolation from data pertaining to the adult immune status and mean that specific pediatric studies are required. No data are available concerning the immune status of adolescents or young adults infected via materno-foetal transmission.
Detailed description:
Our assumption is that the duration of uncontrolled viral replication will affect the immune status after treatment because viral replication is associated with:
- disease progression independently of CD4+ T cell levels;
- accelerated senescence of the immune system;
- destruction of organs involved in the restoration of major immune cell populations.
The aims of the study are:
- to describe the immune and virological status of perinatally infected patients that are above 15 yrs old and
- to study their associations with :
- the current virological/clinical and therapeutic status,
- the duration of uncontrolled viremia (defined by treatment history),
- the virological, immunological (CD4+ numbers), and clinical status at time of HAART initiation.
The immune status will be defined by (1) the number and phenotype of CD4+ and CD8+ T lymphocytes, dendritic cells, regulatory T cells, and NK cells, (2) the functions (proliferation and cytokine production) of CD4+ and CD8+ lymphocytes that are specific for HIV, a recall antigen (tetanus toxoid) and other viruses (CMV, EBV and Flu),the repertoire of Natural Killer cell receptors.
The virological status will be defined by the level of HIV DNA in PBMCs, the HIV subtype, resistance mutations in archived and circulating virus and sequences of the regions of the viral envelope involved in co-receptor use.
Clinical, therapeutic, demographic, virological and immunological data are collected from birth for members of the ANRS CO-10 cohort, and will be collected retrospectively since diagnosis for non-included patients.
- Conditions
- HIV Infections
- Being tested
- A single blood sample (30 mL)
- Keywords
- immune status, adolescents or young adults infected, impact of viral replication
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single blood sample (30 mL)Biological
A single blood sample (30 mL) was drawn during a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood. Cells and plasma were stored and kept frozen for additional biological evaluations
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the immune and virological status of perinatally infected patients that are above 15 yrs old and
Secondary outcomes (1)
To study their associations with the current virological/clinical and therapeutic status, the duration of uncontrolled viremia (defined by treatment history), the virological, immunological (CD4+ numbers), and clinical status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startFeb 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Observational
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Institut Pasteur, University of Paris 5 - Rene Descartes, Hôpital Necker-Enfants Malades
- Investigators
- Warszawski MD Josiane, Methodologist, Study chair, INSERM U 822, Hôpital de Bicêtre, portes 10 à 15, 82 rue du Général Leclerc, 94276 Le Kremlin-Bicêtre Cedex warszaws@vjf.inserm.fr ; Tel : 01 45 21 22 86Blanche PHD Stéphane, Principal investigator, Hopital Necker Enfants malades-Service immunologie hématologie pédiatrique -149 rue de Sèvres- 75015 PARIS 01 44 49 48 24
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055873
- Sponsor's protocol ID
- 2006-AO142-49
- Acronym
- EP38
- Status last verified
- Nov 2010
- First submitted
- 24 Dec 2009
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Avettand-Fenoel V, Blanche S, Le Chenadec J, Scott-Algara D, Dollfus C, Viard JP, Bouallag N, Benmebarek Y, Riviere Y, Warszawski J, Rouzioux C, Buseyne F. Relationships between HIV disease history and blood HIV-1 DNA load in perinatally infected adolescents and young adults: the ANRS-EP38-IMMIP study. J Infect Dis. 2012 May 15;205(10):1520-8. doi: 10.1093/infdis/jis233. Epub 2012 Mar 15.
PubMed 22427678
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunology of the Infection Perinatal
- ClinicalTrials.gov ID
- NCT01055873
- Acronym / sponsor ID
- EP38 / 2006-AO142-49
- Conditions
- HIV Infections
- Keywords
- immune status, adolescents or young adults infected, impact of viral replication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Institut Pasteur, University of Paris 5 - Rene Descartes, Hôpital Necker-Enfants Malades
- Study start
- Feb 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 26 Jan 2010 (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.
ANRS-EP38-IMMIP is a non interventional study. A single blood sample (30 mL) was drawn during a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood. Cells and plasma were stored and kept frozen for additional biological evaluations.
Patients are included in the French perinatal cohort (ANRS CO-10), or have been followed since before 1996 in the same clinical sites as patients who belong to ANRS CO-10. In the ANRS CO-10 cohort, all patients are prospectively followed from birth.
Detailed description
Purpose:
Efficient anti-retroviral treatments lead to a significantly increased life expectancy. Children with perinatal infection are now reaching adulthood. The deleterious impact of viral replication during ontogenesis of the immune system, and the high thymic activity during the early years of life, preclude an extrapolation from data pertaining to the adult immune status and mean that specific pediatric studies are required. No data are available concerning the immune status of adolescents or young adults infected via materno-foetal transmission.
Detailed description:
Our assumption is that the duration of uncontrolled viral replication will affect the immune status after treatment because viral replication is associated with:
- disease progression independently of CD4+ T cell levels;
- accelerated senescence of the immune system;
- destruction of organs involved in the restoration of major immune cell populations.
The aims of the study are:
- to describe the immune and virological status of perinatally infected patients that are above 15 yrs old and
- to study their associations with :
- the current virological/clinical and therapeutic status,
- the duration of uncontrolled viremia (defined by treatment history),
- the virological, immunological (CD4+ numbers), and clinical status at time of HAART initiation.
The immune status will be defined by (1) the number and phenotype of CD4+ and CD8+ T lymphocytes, dendritic cells, regulatory T cells, and NK cells, (2) the functions (proliferation and cytokine production) of CD4+ and CD8+ lymphocytes that are specific for HIV, a recall antigen (tetanus toxoid) and other viruses (CMV, EBV and Flu),the repertoire of Natural Killer cell receptors.
The virological status will be defined by the level of HIV DNA in PBMCs, the HIV subtype, resistance mutations in archived and circulating virus and sequences of the regions of the viral envelope involved in co-receptor use.
Clinical, therapeutic, demographic, virological and immunological data are collected from birth for members of the ANRS CO-10 cohort, and will be collected retrospectively since diagnosis for non-included patients.
Study design
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are included in the French perinatal cohort (ANRS CO-10), or have been followed since before 1996 in the same clinical sites as patients who belong to ANRS CO-10. In the ANRS CO-10 cohort, all patients are prospectively followed from birth
Key inclusion criteria (6 listed)
- Being included in the ANRS CO-10 cohort, or being followed in the same sites as such patients since before 1996
- Being followed in the Paris area
- HIV-1 infected through the perinatal route, and not HIV-2 co-infected
- No therapeutic changes for at least 6 months; single molecule change without modification of viral load is tolerated.
- Informed consent signed by the patients and by their legal guardians for those younger than 18.
Key exclusion criteria (1 listed)
- Not Being affiliated to the French national social security system
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 |
|---|---|---|
| A single blood sample (30 mL)A single blood sample (30 mL) was drawn during a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood. Cells and plasma were stored and kept frozen for additional biological evaluations | Biological | – |
Primary outcome
To describe the immune and virological status of perinatally infected patients that are above 15 yrs old and
1 secondary outcome
To study their associations with the current virological/clinical and therapeutic status, the duration of uncontrolled viremia (defined by treatment history), the virological, immunological (CD4+ numbers), and clinical status
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 18 Nov 2010.
- Derived from this study: PubMed 22427678Avettand-Fenoel V, Blanche S, Le Chenadec J, Scott-Algara D, Dollfus C, Viard JP, Bouallag N, Benmebarek Y, Riviere Y, Warszawski J, Rouzioux C, Buseyne F. Relationships between HIV disease history and blood HIV-1 DNA load in perinatally infected adolescents and young adults: the ANRS-EP38-IMMIP study. J Infect Dis. 2012 May 15;205(10):1520-8. doi: 10.1093/infdis/jis233. Epub 2012 Mar 15.
- 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.
Warszawski MD Josiane, Methodologist study chair
INSERM U 822, Hôpital de Bicêtre, portes 10 à 15, 82 rue du Général Leclerc, 94276 Le Kremlin-Bicêtre Cedex warszaws@vjf.inserm.fr ; Tel : 01 45 21 22 86
Blanche PHD Stéphane principal investigator
Hopital Necker Enfants malades-Service immunologie hématologie pédiatrique -149 rue de Sèvres- 75015 PARIS 01 44 49 48 24
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis.
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 6 inclusion and 1 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 18 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
To describe the immune and virological status of perinatally infected patients that are above 15 yrs old and. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01055873, which also lists 1 linked publication.
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 18 Nov 2010.