Clinical trial NCT03080961: The VIBLOK SAfety and perFormancE Trial
Official title: The VIBLOK SAfety and perFormancE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HSV-2 Infection
Genital Herpes
Keywords: Barrier cream
Lead sponsor: CLJI Worldwide
Sponsor class: INDUSTRY
Collaborators: name: Applied Clinical Services BV
name: UMC Utrecht
name: University of Rotterdam, The Netherlands
name: University of Washington
name: EB FlevoResearch BV
name: PreCare Trial & Recruitment B.V.
First posted: 2017-03-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Trial participants take extra-genital swabs before and after application of the barrier cream.
Primary purpose: PREVENTION

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.


Eligibility 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 the 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 device 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:

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 immune-modulating 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.

Primary outcomes:
measure: Serious Adverse Device Effects
timeFrame: 26-32 days
Secondary outcomes:
measure: HSV-2 Detection Rate in AT Population
timeFrame: 26-32 days
measure: HSV-2 Copy Number in AT Population
timeFrame: 26-32 days
measure: ADE Description
timeFrame: 1-33 days
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: EB FlevoResearch
state: Flevoland
city: Beek
country: Netherlands
facility: PT&R
state: Limburg
city: Utrecht
country: Netherlands
facility: EB UtrechtResearch
Study officials:
affiliation: PreCare Trial & Recruitment B.V.
name: Vivienne vd Walle, MD
role: PRINCIPAL_INVESTIGATOR
References: