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临床试验/NCT04132830
NCT04132830已完成不适用

HIV Exposure In Utero and Metabolic Disease Risk in HIV-Negative Young Adults

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
174
试验地点
1
主要终点
Body mass index (BMI)

研究概览

简要总结

Globally, over 1 million babies are born to mothers with HIV each year. With the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected (HEU). A growing literature suggests that in utero HIV exposure - even in the absence of subsequent infection - may be associated with adverse health outcomes in infancy and childhood. However, there is little information about the long-term health implications of in utero HIV exposure later in life, such as into adulthood. In this study, for the first time, we seek to prospectively evaluate metabolic and immune indices among HEU young adults as compared to well-matched HIV-unexposed uninfected controls. This study serves as a necessary first step toward optimizing clinical care for this expanding and aging HEU population, including the implementation of novel screening and prevention strategies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Body mass index (BMI)

时间窗: Baseline

Activated CD8+ T cells

时间窗: Baseline

Flow cytometry

次要结局

  • Immune cell subsets(Baseline)
  • Frequency of Asthma(Baseline, Ever)
  • DNA methylation patterns(Baseline)
  • Inflammatory markers(Baseline)
  • Glucose tolerance(Baseline)
  • Lipids(Baseline)
  • Blood pressure(Baseline)
  • Hepatic fibrosis(Baseline)
  • Abdominal fat mass(Baseline)
  • Hepatic fat content(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lindsay Fourman, MD

Instructor in Medicine

Massachusetts General Hospital

研究点 (1)

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