Last updated: 03/07/2025 12:10:30

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.

GSK study ID
214523
Clinicaltrials.gov ID
NCT04950712
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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.
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

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

Duration of PCR-confirmed genital HSV-2 recurrences

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

Secondary outcomes:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

HSV-2 PCR self-swab results

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

HSV-2 PCR investigator swab results

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

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

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

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

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

Interventions:
  • Procedure/surgery: Blood sampling
  • Procedure/surgery: Anogenital lesion swab collection
    • Enrollment:
    537
    Primary completion date:
    2024-14-03
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Herpes Genitalis
    Product
    SB208141
    Collaborators
    Not applicable
    Study date(s)
    June 2021 to March 2024
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Man or woman ≥18 years old.
    • Written informed consent obtained from the patient prior to performance of any study-specific procedure.
    • Prior receipt of a vaccine or candidate vaccine containing HSV antigens.
    • Immunocompromised patients, as per medical history and investigator judgement.
    Inclusion and exclusion criteria
    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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Smyrna, GA, United States, 30082
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madrid, Spain, 28010
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Valencia, Spain, 46026
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, FL, United States, 33015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nantes, France, 44093
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saint-Etienne, France, 42055
    Status
    Study Complete
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    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2024-14-03
    Actual study completion date
    2024-14-03

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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