The VIBLOK SAfety and perFormancE Trial

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The VIBLOK SAfety and perFormancE Trial

Conditions
-----------------
HSV-2 Infection, Genital Herpes

Intervention / Treatment
-----------------
* Device: VIBLOK barrier cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Trial participants take extra-genital swabs before and after application of the barrier cream.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Before and after VIBLOK<br>The degree to which HSV-2 is blocked by the VIBLOK cream is determined by comparing the amount of HSV in the external genital area before and after application of the cream. So participants are their own control. | Device: VIBLOK barrier cream<br>* VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Device Effects | Percentage SADE's in the as treated population. | 26-32 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HSV-2 Detection Rate in AT Population | Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK. | 26-32 days | 
| HSV-2 Copy Number in AT Population | Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK. | 26-32 days | 
| ADE Description | Nature and frequency of (possible) device related adverse events. | 1-33 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrier cream