A Double-blind Randomized Placebo Controlled Dose-finding Trial to Investigate Different Doses of a New Antiviral Drug in Subjects With Genital HSV Type 2 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 6
- 主要终点
- Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)
研究概览
简要总结
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of 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
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, Immunocompetent men and women in good health of any ethnic group
- •History of recurrent episodes of genital herpes for at least 12 months
- •Seropositive for Herpes Simplex Virus HSV Type 2
- •Body Mass Index (BMI) between 18 and 35 kg/m2
排除标准
- •Present episode of genital herpes
- •Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
- •Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
- •Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
研究组 & 干预措施
Dose regimen 1
干预措施: AIC316 (Drug)
Dose regimen 2
干预措施: AIC316 (Drug)
Dose regimen 3
干预措施: AIC316 (Drug)
Dose regimen 4
干预措施: AIC316 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)
时间窗: 28 days
Subjects were assessed for shedding rate as the percentage of number of swab days with at least one swab positive for HSV DNA relative to the total number of days with analyzable swabs. Measurement was based on presence of HSV DNA measured on the material collected from swabs taken at the visits by the investigator and daily swabbing of the anogenital region by the patient during the treatment and post-treatment period.
次要结局
未报告次要终点