Impact of in Utero Exposure to Anti-integrase Antiretrovirals on the Newborn Immune System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 5
- 主要终点
- Newborn immunity
研究概览
简要总结
The objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.
详细描述
Antiretroviral treatment during pregnancy is remarkably effective in preventing the transmission of mother-to-child viruses. Molecules of the class of anti-integrases are still little used during pregnancy, but their prescription is increasing given their intrinsic effectiveness and their overall tolerance profile.
The integrase of HIV-1, responsible for the integration of viral DNA in cellular DNA, has a functional similarity with human RAG1 / 2 proteins, responsible for V (D) J recombination. RAG1 / 2 proteins alteration is associated in human clinic with immune disturbances of varied severity.
The objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No parental opposition after information. "Exposed" group :
- •Newborn at term exposed to raltegravir (RTG) before 8 weeks of gestation and until the end of pregnancy. Children exposed to elvitegravir (ETG), dolutegravir (DTG) or bictegravir (BTG) may be included but will be analyzed separately.
- •"Control" group :
- •- Term neonate exposed to antiretroviral therapy without anti-integrase.
排除标准
- •Prematurity less than 36 weeks of gestation.
- •Organ dysfunction.
- •Acute or chronic fetal distress, need for hospitalization in neonatology, malformation syndrome.
研究组 & 干预措施
Newborns exposed
Newborns exposed in-utero to raltegravir
干预措施: Blood test (Biological)
Newborns controls
Newborns exposed to antiretroviral therapy without anti-integrase
干预措施: Blood test (Biological)
结局指标
主要结局
Newborn immunity
时间窗: 18 months
T cells immune repertoire integrity
次要结局
未报告次要终点