Understanding HIV Susceptibility in the Female Genital Tract
研究概览
详细说明
Heterosexual intercourse is the most common mode of transmission of HIV, but the risk of HIV acquisition after exposure is so low that studies to assess HIV risk must have a huge sample size. The goal of this study is to assess the suitability of a prototype pseudovirus assay to identify early HIV target cells in the female genital tract, using cervical cytobrush samples collected from healthy women, and to optimize assay sensitivity.
This novel HIV entry assay may overcome the need for a large sample size by directly measuring how susceptible a person is by using a sample similar to a PAP test. The assay is performed on immune cells obtained from a cervical cytobrush and enables assessment of HIV cell entry within 24 hours. If the assay works, this technique may have the potential to assess the impact of clinical parameters such as stage of menstrual cycle, or sexually transmitted infections and their treatment on HIV susceptibility in the female genital tract. Therefore, the assay may serve as an important monitoring tool in clinical trials of HIV prevention, serving as an invaluable intermediate endpoint to assess HIV acquisition risk, rather than relying on actual participant HIV seroconversion/infection.
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- women over the age of 18 years
Exclusion Criteria:
- pregnant
- actively menstruating
- known HIV infection
- genital ulceration or discharge on history or physical examination
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CD4 cell infection
大体时间:Assay to be conducted within 24 hours of sample collection
|
The absolute number of CD4+ cells per cytobrush that are infected by HIV
|
Assay to be conducted within 24 hours of sample collection
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Type of infected CD4 cells
大体时间:Assay to be conducted within 24 hours of sample collection
|
Nature of the CD4+ cells that are infected, ie: identification of immune characteristics that are associated with preferential HIV cell entry.
Parameters to be assessed include immune activation markers and the expression of HIV coreceptors and integrins.
|
Assay to be conducted within 24 hours of sample collection
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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