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OpenTrials
Completed

NCT Number: NCT05500053

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

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

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Key information

Conditions

Genital Herpes Behavior Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Health Behavior Herpes Genitalis Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Patient Acceptance of Health Care Patient Engagement Patient Participation Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Solent NHS Trust

Southampton, UK, SO10 8BR, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rational Vaccines Inc

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2022
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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