VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Evaluate the potential of seminal HIV infected cells migration and adhesion.
研究概览
简要总结
The objective of our project is to determine the infected seminal cell types and the molecular mechanisms involved in HIV cell-associated transmission in the colo-rectal mucosa, using conditions as close as possible to real life, i.e. seminal leukocytes and seminal plasma from HIV-infected donors and tissue explants
详细描述
This project relies on:
- our expertise of HIV in semen and male genital tract and our experience in organotypic cultures;
- a network of infectious diseases and reproductive biology clinicians to collect, analyze and process seminal cells and seminal plasma from HIV+ donors;
- the expertise in confocal microscopy and ex vivo colo-rectal model. State of the art culture of colo-rectal tissues, primary cell culture and infection, confocal microscopy, flow cytometry, Polymerase Chain Reaction and Luminex assays for cytokine measurements will be the methodologies primarily used in this project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected patients who have never been treated by antiretroviral therapy
- •Signature of informed consent
- •Affiliation to social service
排除标准
- •Patients' general condition not allowing protocol follow-up
- •Patients with an ejaculation disorder
- •Patients unable to perform semen sampling
- •Patients with chemotherapy or radiotherapy antecedents
- •Patients with very severe oligospermia (≤1million/mL of spermatozoa)
- •Patients with active genital infection
- •Protected subjects
结局指标
主要结局
Evaluate the potential of seminal HIV infected cells migration and adhesion.
时间窗: 1 years
Assess the potential of seminal macrophages and CD4 T cells to adhere and transmigrate.
Characterize seminal HIV infected cells.
时间窗: 1 years
Macrophages and CD4+ T lymphocytes characterization.
Determine the efficiency of seminal cell associated infection.
时间窗: 1 years
The efficiency of seminal cell associated infection will be determinated in the colo-rectal explants.
次要结局
- Identify molecules expressed and involved in seminal cell adhesion and transmigration.(1 years)
- Determine the impact of seminal plasma/cells exposure on mucosal immune cell.(1 years)
- Identify seminal and mucosal molecules mediating seminal cell translocation.(1 years)