The VIBLOK SAfety and perFormancE Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 6
- 主要终点
- Serious Adverse Device Effects
研究概览
简要总结
Genital herpes has a high prevalence in industrialized as well as developing countries.
Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be transmitted mother to child during birth with possible serious consequences.
Medical treatments and condoms only partially reduce the risk for transmission from/ to sexual partners. Genital herpes transmission despite use of condoms is thought to be due to transfer via skin-to-skin contact in unprotected areas, and HSV-2 transmission may be enhanced by current shaving habits in the genital area leading to micro lesions (lacerations) of the skin.
VIBLOK™ is a cream designed to impede the passage of viruses, such as HSV-2, across the skin. Bench and animal experiments indicate that it can block virus transmission such as HSV-2 over 80%.
The objective of the SAFE trial is to assess the safety and performance of VIBLOK in adults with HSV-2 infection by comparing virus detection in the extra-genital area before and after application of the barrier cream.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Vials with the sample will be coded. The assessor does not know the coding.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is male or female and at least 18 years of age
- •HSV-2 seropositive by the UW Western blot or Alegria assay
- •History of recurrent genital herpes with at least 3 recurrences in the last year or, if currently on suppressive/ prophylactic therapy, prior to starting the therapy (antiviral therapy has to be stopped at least 7 days prior to initiation of the trial product).
- •General good health at the discretion of the investigator.
- •Willing to not use any topical genital therapy aside from the study device for the duration of the trial.
- •Willing to not use any systemic anti HSV therapy during the entire study starting 7 days prior to baseline.
- •Willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial.
- •Willing to keep a daily trial diary during the treatment period.
- •Negative pregnancy test for women at screening.
- •Willing to use contraceptives for the duration of the study.
- •Subject must be willing and able (in the opinion of the investigator) to understand the patient information and informed consent form and to comply with the clinical trial protocol and procedures.
- •Subject must be willing to give written informed consent.
排除标准
- •Serious medical conditions, such as diabetes, significant autoimmune disease, cancer or immunosuppression, etc. that at the discretion of the investigator will likely affect study outcomes
- •Treatment with systemic steroids or other immune-modulating agents
- •Participation in any investigational drug or device trial within 30 days prior to screening.
- •Pregnancy or breastfeeding, in case of women.
- •Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.
结局指标
主要结局
Serious Adverse Device Effects
时间窗: 26-32 days
Percentage SADE's in the as treated population.
次要结局
- HSV-2 Detection Rate in AT Population(26-32 days)
- ADE Description(1-33 days)
- HSV-2 Copy Number in AT Population(26-32 days)