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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Bondy、フランス
- Hôpital Jean Verdier
-
Colombes、フランス
- Hopital Louis Mourier
-
Créteil、フランス
- Centre Hospitalier Intercommunal
-
Evry、フランス
- Centre hospitalier Francilien Sud
-
Le Kremlin Bicêtre、フランス
- Hôpital Bicêtre
-
Paris、フランス
- Hôpital Trousseau
-
Paris、フランス
- Hopital Robert Debré
-
Paris、フランス
- Groupe Hospitalier Necker
-
Paris、フランス
- Groupe hospitalier Cochin Port Royal
-
Saint Denis、フランス
- Centre Hospitalier Général- Hôpital Delafontaine
-
Villeneuve Saint Georges、フランス
- Centre Hospitalier General
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
|
|
他の: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Immune status
時間枠:Baseline
|
The immune status will be defined by T lymphocyte subpopulations
|
Baseline
|
Virological status
時間枠:Baseline
|
Peripheral blood HIV DNA levels
|
Baseline
|
Immune status
時間枠:6 months after baseline
|
The immune status will be defined by inflammatory parameters : cytokines and chemokines
|
6 months after baseline
|
Immune status
時間枠:Baseline
|
The immune status will be defined by HIV-specific T cell response
|
Baseline
|
Immune status
時間枠:Baseline
|
The immune status will be defined by lymphocyte activation (HLA-DR)
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Comparison of immune and virological statuses of early and late treatment groups
時間枠: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.
|
Baseline
|
Viral reservoir : lymphocyte subpopulation
時間枠:One year after baseline
|
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).
|
One year after baseline
|
Viral reservoir : inductibility
時間枠:One year after baseline
|
Inductibility of the viral reservoir will be quantified by ultrasensitive HIV-RNA RT- PCR in supernatants after coculture of CD4 T cells.
|
One year after baseline
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ANRS EP 59 CLEAC
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HIV感染症の臨床試験
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public Health募集HIV | HIV検査 | HIV とケアの関係 | HIV治療アメリカ
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
-
University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
-
Erasmus Medical Centerまだ募集していません
-
University of Maryland, Baltimore引きこもった
-
Hospital Clinic of Barcelona完了
-
University of WashingtonNational Institute of Mental Health (NIMH)募集
-
Helios SaludViiV Healthcareわからない
採血の臨床試験
-
University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National Human Genome... と他の協力者完了新生児スクリーニング
-
Ischemia Care LLC完了虚血性脳卒中 | 心房細動 | 血栓性脳卒中 | 一過性脳虚血発作 | 心塞栓性脳卒中 | 脳底動脈の脳卒中 | 一過性脳血管イベントアメリカ
-
Applied Science & Performance Institute完了
-
Bedford Hospital NHS TrustAnglia Ruskin Universityわからない