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临床试验/NCT00946556
NCT00946556已完成不适用

Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.

University of Toronto1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

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

Placebo Comparator

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

Experimental

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

Experimental

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)

研究者

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

Rupert Kaul

Dr.

University of Toronto

研究点 (1)

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