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NCT05500053 Clinical Trial

A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease

Patient Engagement Clinical Trial

Official title:
A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05500053
Other study ID # RVx-001-PSS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 3, 2022
Est. completion date December 31, 2022

Study information
Verified date January 2023
Source Rational Vaccines Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Determine the baseline characteristics of patients who have recurrent symptomatic genital herpetic disease Determine the acceptance to patients of clinical trial procedures Determine interest in participation in genital herpes vaccine trials

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Able to understand and willing to sign the informed consent document. - Patient confirmation of a diagnosis of HSV-2 infection at least 2 years prior to inclusion. Laboratory confirmation is not required. - Symptomatic recurrent genital herpetic disease for >2 years supported by compatible clinical history Exclusion Criteria: - Subjects who do not meet the inclusion criteria for the study - Subjects who are unable to provide legally effective informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Solent NHS Trust Southampton UK

Sponsors (1)
Lead Sponsor Collaborator
Rational Vaccines Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Baseline characteristics of patients who have recurrent symptomatic genital herpetic disease To determine using a questionnaire
number of annual outbreaks of patients who have recurrent symptomatic genital herpetic disease
number of patients using suppressiv antiviral therapy
number of patients using antivirals for the treatment of outbreaks
number of patients using symptomatic therapy other than antivirals		 day of questionnaire
Primary Acceptance to patients of clinical trial procedures To determine using a questionnaire
- the acceptance to patients of clinical trial procedures		 day of questionnaire
Primary Interest in participation in genital herpes vaccine trials To determine using a questionnaire the number of patients interested in participation in genital herpes vaccine trials day of questionnaire
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