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

January 17, 2023 updated by: Rational Vaccines Inc
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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • UK
      • Southampton, UK, United Kingdom, SO10 8BR
        • Solent NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with recurrent symptomatic of genital herpes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline characteristics of patients who have recurrent symptomatic genital herpetic disease
Time Frame: day of questionnaire

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
Acceptance to patients of clinical trial procedures
Time Frame: day of questionnaire

To determine using a questionnaire

- the acceptance to patients of clinical trial procedures
day of questionnaire
Interest in participation in genital herpes vaccine trials
Time Frame: day of questionnaire
To determine using a questionnaire the number of patients interested in participation in genital herpes vaccine trials
day of questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rational Vaccines Inc

Investigators

  • Principal Investigator: Rajul Patel, Solent NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVx-001-PSS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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