Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of CD4+ T cells on a cervical cytobrush.
研究概览
简要总结
Herpes simplex virus type 2 (HSV2), the most common cause of genital herpes, increases a woman's risk of HIV acquisition from 3-6 fold, perhaps because HSV2-infected women have increased numbers of HIV "target cells" (CD4 T cells and dendritic cells) in the cervical mucosa. However, recent clinical trials showed no impact of HSV2 suppression on HIV acquisition rates. The reasons for this negative result are unclear. The investigators propose to examine the effect of valacyclovir (a widely used herpes medication) treatment on cervical immunology and HIV target cells in the cervix. The study will take the form of a randomized, double-blind, placebo-controlled crossover trial. Primary endpoints will be (1) the number of CD4 T cells on a cervical cytobrush and (2) the number of immature dendritic cells per cervical cytobrush.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HSV2 infected
排除标准
- •HIV infected
- •Taking HSV2 therapy
- •Current/recent (past 3 months) genital infection
研究组 & 干预措施
Placebo
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
干预措施: Valacyclovir (Drug)
Placebo
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
干预措施: Placebo (Drug)
Valacyclovir
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
干预措施: Valacyclovir (Drug)
Valacyclovir
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of CD4+ T cells on a cervical cytobrush.
时间窗: Monthly intervals for 5 months
次要结局
- Number of immature dendritic cells on a cervical cytobrush(Monthly intervals for 5 months)
- Proinflammatory cytokine/chemokine levels in cervicovaginal secretions(Monthly intervals for 5 months)
