A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of "AIC316 (Pritelivir)" 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Within-subject Genital HSV Mucocutaneous Shedding Rate
研究概览
简要总结
The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.
详细描述
Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •Adult, immunocompetent men and women in good health of any ethnic group
- •Seropositive for Herpes Simplex Virus Type 2 (HSV-2)
- •History of recurrent episodes (>=4 to <=9) of genital herpes for at least 12 months and willingness to obtain 4 swabs per day.
排除标准
- •Present episode of genital herpes at time of randomization
- •Clinically relevant acute or chronic infections (excluding HSV-2)
- •Known intolerance to valacyclovir, acyclovir, or any component of the formulation
- •Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir
研究组 & 干预措施
AIC316, Then Valacyclovir
Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days.
干预措施: AIC316 (Drug)
AIC316, Then Valacyclovir
Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days.
干预措施: Valacyclovir (Drug)
Valacyclovir, Then AIC316
Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days.
干预措施: AIC316 (Drug)
Valacyclovir, Then AIC316
Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days.
干预措施: Valacyclovir (Drug)
结局指标
主要结局
Within-subject Genital HSV Mucocutaneous Shedding Rate
时间窗: 28 days
Subjects were assessed for within-subject genital HSV mucocutaneous shedding rate, as calculated by the number of HSV-positive swabs per subject relative to the total number of swabs collected per subject. The swab test detects the presence of herpes virus DNA. A swab was regarded as positive for HSV-DNA if at least 3 HSV genome copies were detected by quantitative PCR per reaction (equaling 150 copies per mL of swab collection medium). When multiple swabs were available from the same time point (e.g., genital and lesional swab), the swab with the highest copy number was retained for computation of the shedding rate.
Overall Shedding Rate
时间窗: 28 days
Subjects were assessed for overall shedding rate as the total number of HSV-positive swabs per treatment group divided by the number of swabs collected per treatment group.
次要结局
未报告次要终点