An observational study in Herpes Genitalis, sponsored by GlaxoSmithKline. Completed at 51 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by GlaxoSmithKline · Observational
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Among 11 studies in Herpes Genitalis by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Herpes Genitalis · GlaxoSmithKline.
Among the 11 studies in Herpes Genitalis by GlaxoSmithKline, this one is the only one that started in 2021, is one of 2 observational ones, and was the 10th registered.
70 studies on the registry are indexed under Herpes Genitalis; 3 are open to participants now.
Browse Herpes Genitalis studies →None of the 11 studies in Herpes Genitalis by GlaxoSmithKline is open now. The open studies under Herpes Genitalis, anywhere →
Of the 1 Herpes Genitalis study recruiting now, none set no upper age limit and 1 stops at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 1 started in 2021.
This study's enrollment of 537 is above the median of 300 across 13 observational studies indexed under Herpes Genitalis.
Median enrollment 72 across the 6 interventional studies, 500 across the 2 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Herpes Genitalis by GlaxoSmithKline, from their registry updates:
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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.
Patients will be recruited in specific community settings in the United States and in Europe. Screening logs will be used to assess participation rate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Blood sampling · Procedure: Anogenital lesion swab collection
Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).
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.
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.
Time frame: 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).
Time frame: During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)
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)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Mar 2024, 33 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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