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Completed

NCT Number: NCT04950712

An Epidemiological Study to Assess Performance of Using Healthcare Tools to Understand Genital Herpes Simplex Virus-2 (HSV-2) in Patients ≥ 18 Years of Age in the United States and Europe.

The aim of this study is to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe.

More specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well as the performance study procedures in a decentralised setting. Ultimately, this study will allow generating additional real-world evidence (RWE) on patterns of recurrences and other key parameters.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Man or woman ≥18 years old.
  • Written informed consent obtained from the patient prior to performance of any study-specific procedure.
  • History of at least one episode of HSV-2 genital herpes lesions in the 12 months preceding the screening, and seropositive for HSV-2 as determined by Western blot OR PCR-positive for HSV-2 (newly diagnosed patients).
  • Patients who are medically stable in the opinion of the investigator.
  • Patients who, in the opinion of the investigator, are able to understand and comply with the study requirements (attend regular telephone calls/study site visits/home visits/self-completion of questionnaires, self-swabbing).
  • Seronegative for HIV, as determined by laboratory testing. Patients documented to be positive to HIV will not be eligible for study participation

Exclusion criteria

  • Prior receipt of a vaccine or candidate vaccine containing HSV antigens.
  • Immunocompromised patients, as per medical history and investigator judgement.
  • Other genital tract disorders or sexually transmitted diseases that may interfere with the assessment of the study (as per investigator's judgement).

Treatment and study plan

blood sampling

Procedure

Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).

Anogenital lesion swab collection

Procedure

Anogenital lesion swab of all lesions are collected at screening visit (only for newly infected HSV-2 patients) and at first genital HSV-2 recurrence during the study period.

Primary outcomes

  1. Number of patients with Polymerase Chain Reaction (PCR)-confirmed genital HSV-2 recurrences

    Time frame: During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)

    Genital HSV-2 recurrence is defined as presence of lesions in anogenital area (swelling, blisters, sores, crusts) and, a positive HSV-2 PCR test.

  2. Duration of PCR-confirmed genital HSV-2 recurrences

    Time frame: During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)

    Duration of a recurrence is defined as number of consecutive days with the presence of HSV-2 lesion(s) and associated prodromal symptoms and/or erythema (skin redness).

Secondary outcomes

  1. Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of severity (PGI-S) questionnaire

    Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)

  2. Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of change (PGI-C) questionnaire

    Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)

  3. Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes symptoms checklist (HSC) questionnaire

    Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)

  4. Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes outbreak impact (HOIQ) questionnaire

    Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)

  5. Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HSC questionnaire

    Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)

  6. Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HOIQ questionnaire

    Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)

  7. Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by EuroQoL-5 dimension (EQ-5D) health questionnaire

    Time frame: At Enrolment Visit (Day 1) and at Day 1 of each PCR-confirmed recurrence

  8. Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by Recurrent genital herpes quality-of-life (RGHQoL) questionnaire

    Time frame: At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24

  9. Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by short form-12 questionnaire

    Time frame: At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24

  10. Number of self-swabs collected during genital HSV-2 recurrences throughout the study period

    Time frame: Throughout the study period (from Day 1 up to Month 24)

  11. HSV-2 PCR self-swab results

    Time frame: At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)

  12. HSV-2 PCR investigator swab results

    Time frame: At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)

  13. Number of patients reporting genital HSV-2 recurrences by using eDiary

    Time frame: Throughout the study period (from Day 1 up to Month 24)

  14. Number of patients reporting genital HSV-2 recurrence during the 3 monthly calls with the investigator

    Time frame: Throughout the study period (from Day 1 up to Month 24)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Descriptive, Prospective, Multi-country, Multicentre Study to Assess Performance of Genital Herpes Simplex Virus-2 (HSV-2) Related Disease Endpoints Based on Patient-reported Health Outcomes, Self-swabbing Collected Via Decentralised Approach in Patients ≥ 18 Years of Age in the United States and Europe.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2021
Registry last updated
Mar 7, 2025

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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