- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02674867
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Bondy, Francie
- Hôpital Jean Verdier
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Colombes, Francie
- Hôpital Louis Mourier
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Créteil, Francie
- Centre Hospitalier Intercommunal
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Evry, Francie
- Centre hospitalier Francilien Sud
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Le Kremlin Bicêtre, Francie
- Hôpital Bicêtre
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Paris, Francie
- Hôpital Trousseau
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Paris, Francie
- Hôpital Robert Debré
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Paris, Francie
- Groupe Hospitalier Necker
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Paris, Francie
- Groupe hospitalier Cochin Port Royal
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Saint Denis, Francie
- Centre Hospitalier Général- Hôpital Delafontaine
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Villeneuve Saint Georges, Francie
- Centre Hospitalier General
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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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Jiný: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Immune status
Časové okno: Baseline
|
The immune status will be defined by T lymphocyte subpopulations
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Baseline
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Virological status
Časové okno: Baseline
|
Peripheral blood HIV DNA levels
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Baseline
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Immune status
Časové okno: 6 months after baseline
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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
Časové okno: 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
Časové okno: Baseline
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The immune status will be defined by lymphocyte activation (HLA-DR)
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Baseline
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Comparison of immune and virological statuses of early and late treatment groups
Časové okno: Baseline
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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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ANRS EP 59 CLEAC
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