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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05500053
Recruitment Status : Active, not recruiting
First Posted : August 12, 2022
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Rational Vaccines Inc

Brief 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

Condition or disease
Genital Herpes Patient Engagement

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease
Actual Study Start Date : August 3, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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


  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with recurrent symptomatic of genital herpes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05500053


Locations
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United Kingdom
Solent NHS Trust
Southampton, UK, United Kingdom, SO10 8BR
Sponsors and Collaborators
Rational Vaccines Inc
Investigators
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Principal Investigator: Rajul Patel Solent NHS Trust
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Responsible Party: Rational Vaccines Inc
ClinicalTrials.gov Identifier: NCT05500053    
Other Study ID Numbers: RVx-001-PSS
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Herpes Genitalis
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
Infections
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases