Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
研究概览
简要总结
Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In overall general good health.
- •HSV-2 (Herpes Simplex Virus-2) seropositive at screening.
- •Exclusion criteria:
- •have active lesions consistent with genital herpes.
- •previous history of symptomatic genital herpes.
- •history of recurrent, undiagnosed symptoms consistent with genital herpes.
排除标准
- 未提供
研究组 & 干预措施
Sequence 1: VALTREX 1 g once daily, Placebo
VALTREX 1 g once daily, Placebo
干预措施: Valaciclovir (Drug)
Sequence 1: VALTREX 1 g once daily, Placebo
VALTREX 1 g once daily, Placebo
干预措施: Placebo (Drug)
Sequence 2: Placebo, VALTREX 1 g once daily
Placebo, VALTREX 1 g once daily
干预措施: Valaciclovir (Drug)
Sequence 2: Placebo, VALTREX 1 g once daily
Placebo, VALTREX 1 g once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
时间窗: Up to Day 60 of each treatment period (up to 160 days)
Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
次要结局
- Number of Participants With no Shedding(Up to Day 60 of each treatment period (up to 160 days))
- Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding(Up to Day 60 of each treatment period (up to 160 days))
- Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding(Up to Day 60 of each treatment period (up to 160 days))
- Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study(Up to Day 60 of each treatment period (up to 160 days))
- Mean Percent Days of Total HSV-2 Shedding(Up to Day 60 of each treatment period (up to 160 days))