NCT06302933招募中不适用
Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 451
- 试验地点
- 3
- 主要终点
- Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
研究概览
简要总结
The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in Cameroon
The hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives:
- Immunological aspect: lack of humoral response or immune activation
- Virological aspect: Reduced HIV reservoir size
- Determine the HLA phenotype in the different groups of children included and the KIR genotypes.
详细描述
There will be two phases of the study :
- A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.
- A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Case control study
- •Children included and followed in the ANRS 12225 study - Pediacam III
- •Having plasma samples in the bio bank during the above-mentioned periods Case:children with at least one negative HIV serology made by ELISA, permanent or transientduring follow-up.
- •Control (4 groups)
- •HIV-infected children with positive serology and viral load (VL) <400 copies /ml
- •HIV-infected children with positive serology and VL ≥400 copies / ml
- •HIV-uninfected children born to HIV-positive mothers
- •HIV-uninfected children born to HIV-uninfected mothers Selection of cases and controls will be matched on gestational age (premature <37, term ≥37 weeks) and year of birth (2007-2008 and 2009-2010).
- •Cross sectional study Inclusion criteria
- •All children still followed in the ANRS - Pediacam III cohort
- •Written consent of one of the parents or the guardian and assent of the child if aged ≥ 11 years and complete disclosure of HIV statusfor infected children for participation to the study.
排除标准
- •Refusal by one of the parents or the guardian for the child's participation in the study
- •No assent of the child (if aged ≥ 11 years and with complete disclosure of HIV status, for infected children)
研究组 & 干预措施
Children enrolled in Pediacam III ANRS12225 cohort
Other
干预措施: Blood sampling (Biological)
结局指标
主要结局
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
时间窗: 18 months
Measure of TRAIL (ng/ml). Levels of these biomarkers will be compared across all groups
次要结局
- - Size of the HIV reservoir(18 months)
- - Residual viremia in perinatally HIV-infected adolescent(18 months)
- - Level of HIV plasma p24(18 months)
- - Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B(18 months)
- - Functional and phenotypic characterization of B and T lymphocytes(18 months)
- - HLA phenotype and the KIR genotypes(18 months)
研究者
研究点 (3)
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