An International, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6-Month Study of the Efficacy and Safety of Valtrex 1g QD vs. Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Time to First GH Recurrence
研究概览
简要总结
Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.
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
- Single (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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Valaciclovir
Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks).
干预措施: Valaciclovir (Drug)
Placebo
Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks).
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Time to First GH Recurrence
时间窗: Day 168
Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The percentage of participants with time to first GH recurrence was based on Kaplan-Meier estimates. Confidence intervals for differences in proportions was calculated using the standard error for the Kaplan-Meier estimate derived using Greenwood's formula.
次要结局
- Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months(Day 168)
- Number of Isolates With Resistance to Acyclovir (ACV)(Day 168)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Upto Day 168)
- Mean Number of GH Recurrences Per Month Within the 6-month Study Period(Up to Day 168)