CLEAC (Comparison of Late Versus Early Antiretroviral Therapy in HIV-infected Children) (CLEAC)
ANRS EP59 CLEAC : Physiopathological Study of Immunovirological Evolution of Perinatally HIV-1 Infected Children Depending on Early (Before 6 Months) or Late (After 2 Years) Antiretroviral Therapy Introduction.
The study aims to define and compare the immunological characteristics (lymphocyte subpopulations, specific immunity against HIV, lymphocyte activation, inflammatory parameters) and the virological characteristics (study of viral reservoir) between 2 groups of vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia.
Moreover, the viral reservoir will be deeply characterized in 10 children (5 patients in each group) with sustained control of the HIV-1 viremia under cART (≥ 90% of HIV-1 RNA measures <400 copies /mL): quantification of the reservoir in the lymphocyte subpopulations and study of the inductibility of the viral reservoir.
Studieoversikt
Detaljert beskrivelse
This is a cross-sectional study, multicenter, without direct benefit, among vertically HIV-1 infected children, aged 5 to 17 years, followed in centers participating in the ANRS CO10 EPF cohort located in Ile-de-France. Eligible children are not necessarily included in the cohort. The sample will consist of two age groups of equal size (5-12 years and 13-17 years).
Patient recruitment will be conducted in the centers of the ANRS CO10 EPF cohort located in Ile de France (Paris area). 80 children will be included, previously included or not in the ANRS CO10 EPF cohort. Our investigations will involve two blood samples, taken during two successive visits of the children in the hospitals where they are usually followed. Finally, a third blood sample will be taken during a third visit only for the 10 children participating in the substudy of the viral reservoir. All medical data since birth will be prospectively collected for children included in the ANRS CO10 EPF cohort, and retrospectively collected in the other cases.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Bondy, Frankrike
- Hôpital Jean Verdier
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Colombes, Frankrike
- Hôpital Louis Mourier
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Créteil, Frankrike
- Centre Hospitalier Intercommunal
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Evry, Frankrike
- Centre hospitalier Francilien Sud
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Le Kremlin Bicêtre, Frankrike
- Hôpital Bicêtre
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Paris, Frankrike
- Hôpital TROUSSEAU
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Paris, Frankrike
- Hopital Robert Debre
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Paris, Frankrike
- Groupe Hospitalier Necker
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Paris, Frankrike
- Groupe hospitalier Cochin Port Royal
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Saint Denis, Frankrike
- Centre Hospitalier Général- Hôpital Delafontaine
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Villeneuve Saint Georges, Frankrike
- Centre Hospitalier Général
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 5 to 17 years old
- Vertically HIV-1 infected, not HIV-2 co-infected
- Diagnosed < 13 years old
- Usually followed in a center participating in the ANRS CO10 EPF cohort located in Ile de France
Have received cART treatment:
- started later than 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group)
- with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART),
- Affiliated person or beneficiary of a social security system (Article L1121-11 of the Code of Public Health) (medical aid of state or AME is not a social security system)
- Participant agreement if in age to give an opinion
- Free, informed and written consent, signed by at least one parent and the investigator
Exclusion Criteria:
- < 5 years old or ≥ 18 years old at first sample for the study
- Obviously HIV-1 infected after the perinatal period
- HIV-2 co-infected
- Diagnosed ≥ 13 years old
- Started cART treatment between 7 and 23 months
- No HIV-1 RNA <400 copies / mL within 24 months after initiation of treatment (considered as a failure of the first line therapy)
- Not affiliated to the French social security, or beneficiary of a social security system
- Refusal to participation of parent(s) (or the holders(s) of parental authority)
- Refusal to participation if in age to give an opinion.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Early treatment group
Vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before 6 months-of-age ("early treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia.
|
|
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Annen: Late treatment group
Vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Immune status
Tidsramme: Baseline
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The immune status will be defined by T lymphocyte subpopulations
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Baseline
|
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Virological status
Tidsramme: Baseline
|
Peripheral blood HIV DNA levels
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Baseline
|
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Immune status
Tidsramme: 6 months after baseline
|
The immune status will be defined by inflammatory parameters : cytokines and chemokines
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6 months after baseline
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Immune status
Tidsramme: Baseline
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The immune status will be defined by HIV-specific T cell response
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Baseline
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Immune status
Tidsramme: Baseline
|
The immune status will be defined by lymphocyte activation (HLA-DR)
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Baseline
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of immune and virological statuses of early and late treatment groups
Tidsramme: Baseline
|
Two groups of vertically-HIV-1-infected children, between 5 and 18-year-of-age, will be compared: the "early treatment" group that comprises children who started HAART before 6 months-of-age, and the late treatment" group those who started HAART after 24 months-of-age.
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Baseline
|
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Viral reservoir : lymphocyte subpopulation
Tidsramme: One year after baseline
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Total HIV- DNA will be quantified by ultrasensitive PCR in CD4 T cell subsets sorted according their differenciation status for 10 children (5 patients in each group) with sustained control of the HIV-1 viremia under HAART ( ≥ 90% of HIV-1 RNA measures <400 copies / ml).
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One year after baseline
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Viral reservoir : inductibility
Tidsramme: One year after baseline
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Inductibility of the viral reservoir will be quantified by ultrasensitive HIV-RNA RT- PCR in supernatants after coculture of CD4 T cells.
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One year after baseline
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ANRS EP 59 CLEAC
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