genital herpes HSV-2
Conditions
Interventions
Sponsors
CLJI Worldwide
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Participant is male or female and at least 18 years of age 2. HSV-2 seropositive by the UW Western blot or Alegria assay 3. 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 trial product). 4. General good health at the discretion of the investigator. 5. Willing to not use any topical genital therapy aside from the study drug for the duration of the trial. 6. Willing to not use any systemic anti HSV therapy during the entire study starting 7 days prior to baseline. 7. Willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial. 8. Willing to keep a daily trial diary during the treatment period. 9. Negative pregnancy test for women at screening. 10. Willing to use contraceptives for the duration of the study. 11. 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. 12. Subject must be willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. 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 2. Treatment with systemic steroids or other immunomodulating agents 3. Participation in any investigational drug or device trial within 30 days prior to screening 4. Pregnancy or breastfeeding, in case of women 5. Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious Adverse Device Effect incidence during the period using VIBLOK cream. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Comparison of HSV-2 DNA detection rate on days with asymptomatic shedding prior and after applying VIBLOK * Comparison of HSV-2 DNA copy number on days with asymptomatic shedding prior and after applying VIBLOK * Safety (Nature, frequency, duration, severity, seriousness and causality of adverse events) | — |
Countries
The Netherlands
Outcome results
None listed