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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Bondy, 프랑스
- Hôpital Jean Verdier
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Colombes, 프랑스
- Hôpital Louis Mourier
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Créteil, 프랑스
- Centre Hospitalier Intercommunal
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Evry, 프랑스
- Centre hospitalier Francilien Sud
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Le Kremlin Bicêtre, 프랑스
- Hôpital Bicêtre
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Paris, 프랑스
- Hôpital TROUSSEAU
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Paris, 프랑스
- Hopital Robert Debre
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Paris, 프랑스
- Groupe Hospitalier Necker
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Paris, 프랑스
- Groupe hospitalier Cochin Port Royal
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Saint Denis, 프랑스
- Centre Hospitalier Général- Hôpital Delafontaine
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Villeneuve Saint Georges, 프랑스
- Centre Hospitalier Général
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Immune status
기간: 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
기간: Baseline
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Peripheral blood HIV DNA levels
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Baseline
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Immune status
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Comparison of immune and virological statuses of early and late treatment groups
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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