Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in ectocervical permeability
研究概览
简要总结
Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).
详细描述
Feminization of the HIV pandemic is impetus for better understanding of the risk factors promoting male to female sexual transmission. One putative risk factor is hormonal contraceptive use. Our laboratory recently reported that dendritic cell activation, virus-specific T cell expansion, and memory T cell development were impaired among female mice administered depot-medroxyprogesterone acetate (DMPA) prior to viral infection of mucosal tissue, and we now are enrolling women into a clinical investigation exploring the immunomodulatory effects of several common hormonal contraceptive forms. Completion of this research will provide important comparative evaluation of the capacity of these drugs to modulate host defenses combating genital tract infection, eventually supplying healthcare providers more informed recommendations regarding appropriate hormonal contraceptive choices among women at risk for acquisition of HIV.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •not pregnant
- •regular menstrual cycle
排除标准
- •use of oral contraceptive or Mirena in 3 months prior to enrollment
- •use of depot-medroxyprogesterone acetate in 6 months prior to enrollment
- •diagnosis of sexually transmitted infection in 30 days prior to enrollment
- •history of cervical malignancy
结局指标
主要结局
Change in ectocervical permeability
时间窗: Baseline and 1 month
次要结局
未报告次要终点
研究者
Thomas L. Cherpes
Assistant Professor
Stanford University