Herpes GenitalisNCT04950712
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.
An observational study of Herpes Genitalis, run by GlaxoSmithKline at 51 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Genitalis
- What is being tested?
- Blood sampling and Anogenital lesion swab collection
- Type of treatment
- Surgery or procedure
- How many people
- 537 participants
- Where
- 51 sitesin 6 countries
- Study dates
- 9 Jun 2021to 14 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited in specific community settings in the United States and in Europe. Screening logs will be used to assess participation rate.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
51 sites in 6 countries.
51 sites in 6 countries
United States22 sites
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Columbus, Ohio, 43213
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Houston, Texas, 77339
GSK Investigational Site
Kansas City, Missouri, 64111
GSK Investigational Site
Lawrenceville, New Jersey, 08648
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
Marietta, Georgia, 30067
GSK Investigational Site
Memphis, Tennessee, 38129
GSK Investigational Site
Miami, Florida, 33015
GSK Investigational Site
Miami, Florida, 33126
GSK Investigational Site
Miami, Florida, 33134
GSK Investigational Site
Newark, New Jersey, 07103
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Plantation, Florida, 33317
GSK Investigational Site
Richmond, Virginia, 23235
GSK Investigational Site
San Francisco, California, 94102
GSK Investigational Site
Smyrna, Georgia, 30082
GSK Investigational Site
St Louis, Missouri, 63108
Spain8 sites
GSK Investigational Site
Alcorcón, 28922
GSK Investigational Site
Barcelona, 08001
GSK Investigational Site
Madrid, 28010
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Marbella, 29600
GSK Investigational Site
Oviedo, 33011
GSK Investigational Site
Valencia, 46026
France7 sites
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75010
GSK Investigational Site
Paris, 75679
GSK Investigational Site
Pierre-Bénite, 69495
GSK Investigational Site
Saint-Etienne, 42055
GSK Investigational Site
Toulouse, 31059
United Kingdom7 sites
GSK Investigational Site
Birmingham, B4 6DH
GSK Investigational Site
Brighton, BN2 1ES
GSK Investigational Site
Leeds Yorkshire, LS2 8NG
GSK Investigational Site
Liverpool, L7 8YE
GSK Investigational Site
London, SE1 0UN
GSK Investigational Site
London, WC1E 6JB
GSK Investigational Site
Southampton, SO14 0YG
Italy4 sites
GSK Investigational Site
Bari, 70120
GSK Investigational Site
Milan, 20127
GSK Investigational Site
Palermo, 90127
GSK Investigational Site
Roma, 00144
Finland3 sites
GSK Investigational Site
Helsinki, 00250
GSK Investigational Site
Oulu, 90100
GSK Investigational Site
Tampere, FI-33100
About this study
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.
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.
- Conditions
- Herpes Genitalis
- Being tested
- Blood sampling, Anogenital lesion swab collection
- Keywords
- Herpes Simplex Virus-2, HSV-2 genital herpes, HSV-2 recurrence
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).
Anogenital lesion swab collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood sampling; Procedure: Anogenital lesion swab collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)
Secondary outcomes (14)
Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of severity (PGI-S) questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Throughout the study period (from Day 1 up to Month 24)
HSV-2 PCR self-swab results
Measured: At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
HSV-2 PCR investigator swab results
Measured: 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
Measured: 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
Measured: Throughout the study period (from Day 1 up to Month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start9 Jun 2021
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes GenitalisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950712
- Sponsor's protocol ID
- 214523
- Status last verified
- Mar 2025
- First submitted
- 9 Jun 2021
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04950712
- Acronym / sponsor ID
- 214523
- Conditions
- Herpes Genitalis
- Keywords
- Herpes Simplex Virus-2, HSV-2 genital herpes, HSV-2 recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Study Group | – | Procedure: Blood sampling, Procedure: Anogenital lesion swab collectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in specific community settings in the United States and in Europe. Screening logs will be used to assess participation rate.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit). | Procedure or surgery | Overall Study Group |
| Anogenital lesion swab collectionAnogenital 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. | Procedure or surgery | Overall Study Group |
Primary outcome
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.
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).
14 secondary outcomes
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)
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)
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)
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)
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)
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)
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
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
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
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)
HSV-2 PCR self-swab results
Time frame: At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
HSV-2 PCR investigator swab results
Time frame: 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
Time frame: 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
Time frame: Throughout the study period (from Day 1 up to Month 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
51 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Genitalis, run by GlaxoSmithKline at 51 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Spain, France, United Kingdom, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.