The objective of this clinical 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.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Skin and subcutaneous tissue disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serious Adverse Device Effect incidence during the period using VIBLOK cream.
Secondary outcome
* 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)
Background 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 (HIV, HPV, HSV) up to 98%.
Study objective
The objective of this clinical 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.
Study design
The VIBLOK SAfety and perFormancE Trial is a prospective, non-randomized,
comparative multi-center safety and performance study. Up to 48 HSV-2 infected
adults are planned to be enrolled at up to 6 participating investigational
centers in The Netherlands and Germany. Participants are planned to be
followed for 26-31 days, using VIBLOK for minimally 26 days in a row. Safety
will be assessed by collecting all adverse events, and HSV detection will be
measured from daily self-collected external genital swabs before and after
application of VIBLOK.
Intervention
Please refer to the below section on study participant burden.
Study burden and risks
Risks are as follows: Unanticipated serious adverse device effects.
The burden for the study subjects is as follows:
1. for the duration of ~28 days, daily swabs before and after application of
the barrier cream, marking, storing, and bring the samples to the clinic during
the follow-up visit.
2. daily completion of a diary about sampling, possible herpes symptoms, and
shaving and waxing habits.
3. 4 visits to the clinic: screening, inclusion/ instruction, after 14 days of
sampling, and after 28 days of sampling
4. 1 follow-up phone-call with the (research) clinic: (re)-instruction study
procedures, 2-5 days after start sampling
5. completion of a participants questionnaire during the last visit at the
clinic.
Kane Concourse, Suite 103 1177
Bay Harbor Islands FL33154
US
Kane Concourse, Suite 103 1177
Bay Harbor Islands FL33154
US
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58709.072.16 |