NCT00129818已完成4 期
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 试验地点
- 14
- 主要终点
- Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
研究概览
简要总结
The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes
排除标准
- •Pregnancy
- •History of renal dysfunction
- •Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid
- •Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure
结局指标
主要结局
Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions
次要结局
- reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
- quantitative HSV DNA PCR, during the days with positive HSV-2 shedding.
- time to the first recurrence of genital herpes and number of genital herpes recurrence episodes
- oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients
- reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
研究者
研究点 (14)
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