The VIBLOK SAfety and perFormancE Trial

NCT03080961 | Completed Results DMC

• 1 other identifier: 2015-01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

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.

Conditions

HSV-2 Infection; Genital Herpes

Keywords

Barrier cream

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Device Effects

  Percentage SADE's in the as treated population.

  26-32 days

Secondary Outcomes (3)

• HSV-2 Detection Rate in AT Population

  26-32 days

• HSV-2 Copy Number in AT Population

  26-32 days

• ADE Description

  1-33 days

Study Arms (1)

Before and after VIBLOK

EXPERIMENTAL

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

Interventions

VIBLOK barrier cream DEVICE

VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.

Before and after VIBLOK

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CLJI Worldwide: lead
• Applied Clinical Services BV: collaborator
• UMC Utrecht: collaborator
• University of Rotterdam, The Netherlands: collaborator
• University of Washington: collaborator
• EB FlevoResearch BV: collaborator
• PreCare Trial & Recruitment B.V.: collaborator

Study Sites (3)

EB FlevoResearch

Almere Stad, Flevoland, 1311 RL, Netherlands

Location

PT&R

Beek, Limburg, 6191 JW, Netherlands

Location

EB UtrechtResearch

Utrecht, 3511 NH, Netherlands

Location

MeSH Terms

Conditions

Herpes Genitalis

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Results Point of Contact

• Title: Ty Cross, President & CEO
• Organization: CLJI WORLDWIDE

tycross@cljiworldwide.com

305-397-8880

Study Officials

• Vivienne vd Walle, MD

  PreCare Trial & Recruitment B.V.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Vials with the sample will be coded. The assessor does not know the coding.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Trial participants take extra-genital swabs before and after application of the barrier cream.

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 15, 2017
• Study Start: March 27, 2017
• Primary Completion: November 13, 2017
• Study Completion: November 13, 2017
• Last Updated: February 13, 2020
• Results First Posted: February 13, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)