Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Time to Healing of Genital Lesions
研究概览
简要总结
To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HIV negative as determined by concordant rapid testing
- •HSV-2 seropositive (Focus HerpeSelect >3.4)
- •At least one prior occurrence of GUD
- •18-50 years of age
排除标准
- •Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir
- •Prior hypersensitivity &/or allergic reaction to acyclovir
- •Use of probenicid
- •Current use, or use within past 28 days, of an investigational agent
- •Currently pregnant or nursing
- •Currently plan to become pregnant during next 3 months
- •Any condition that will interfere with successful completion of study procedures
研究组 & 干预措施
placebo
干预措施: matching placebo (Drug)
acyclovir
干预措施: acyclovir (Drug)
结局指标
主要结局
Time to Healing of Genital Lesions
时间窗: Days 1-5, 7, 9, 11, 13
To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo
次要结局
- Time to First Negative Herpes Simplex Virus (HSV) DNA PCR(Days 1-5, 7, 9, 11, 13)
研究者
Connie Celum
MPH/ Principal Investigator, Protocol Co-Chair
University of Washington