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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall Study Group | Patients aged 18 years old or above, with HSV-2 genital herpes, who are recruited in specific community settings in the United States and in Europe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Polymerase Chain Reaction (PCR)-confirmed genital HSV-2 recurrences | Genital HSV-2 recurrence is defined as presence of lesions in anogenital area (swelling, blisters, sores, crusts) and, a positive HSV-2 PCR test. | 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 | 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). | During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of severity (PGI-S) questionnaire | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited in specific community settings in the United States and in Europe. Screening logs will be used to assess participation rate.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Long Beach | California | 90806 | United States | ||
| GSK Investigational Site |
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| 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. |
|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Throughout the study period (from Day 1 up to Month 24) |
| HSV-2 PCR self-swab results | At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months) |
| HSV-2 PCR investigator swab results | 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 | 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 | Throughout the study period (from Day 1 up to Month 24) |
| Los Angeles |
| California |
| 90027 |
| United States |
| GSK Investigational Site | San Francisco | California | 94102 | United States |
| GSK Investigational Site | Miami | Florida | 33015 | United States |
| GSK Investigational Site | Miami | Florida | 33126 | United States |
| GSK Investigational Site | Miami | Florida | 33134 | United States |
| GSK Investigational Site | Plantation | Florida | 33317 | United States |
| GSK Investigational Site | Marietta | Georgia | 30067 | United States |
| GSK Investigational Site | Smyrna | Georgia | 30082 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64111 | United States |
| GSK Investigational Site | St Louis | Missouri | 63108 | United States |
| GSK Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| GSK Investigational Site | Newark | New Jersey | 07103 | United States |
| GSK Investigational Site | Columbus | Ohio | 43213 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38129 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Houston | Texas | 77054 | United States |
| GSK Investigational Site | Houston | Texas | 77339 | United States |
| GSK Investigational Site | Richmond | Virginia | 23235 | United States |
| GSK Investigational Site | Helsinki | 00250 | Finland |
| GSK Investigational Site | Oulu | 90100 | Finland |
| GSK Investigational Site | Tampere | FI-33100 | Finland |
| GSK Investigational Site | Montpellier | 34295 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Paris | 75010 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Pierre-Bénite | 69495 | France |
| GSK Investigational Site | Saint-Etienne | 42055 | France |
| GSK Investigational Site | Toulouse | 31059 | France |
| GSK Investigational Site | Bari | 70120 | Italy |
| GSK Investigational Site | Milan | 20127 | Italy |
| GSK Investigational Site | Palermo | 90127 | Italy |
| GSK Investigational Site | Roma | 00144 | Italy |
| GSK Investigational Site | Alcorcón | 28922 | Spain |
| GSK Investigational Site | Barcelona | 08001 | Spain |
| GSK Investigational Site | Madrid | 28010 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Marbella | 29600 | Spain |
| GSK Investigational Site | Oviedo | 33011 | Spain |
| GSK Investigational Site | Valencia | 46026 | Spain |
| GSK Investigational Site | Birmingham | B4 6DH | United Kingdom |
| GSK Investigational Site | Brighton | BN2 1ES | United Kingdom |
| GSK Investigational Site | Leeds Yorkshire | LS2 8NG | United Kingdom |
| GSK Investigational Site | Liverpool | L7 8YE | United Kingdom |
| GSK Investigational Site | London | SE1 0UN | United Kingdom |
| GSK Investigational Site | London | WC1E 6JB | United Kingdom |
| GSK Investigational Site | Southampton | SO14 0YG | United Kingdom |
| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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