blood sampling
ProcedureBlood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).
NCT Number: NCT04950712
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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Notify Me18 year and older
All sexes
Observational
GSK Investigational Site, Helsinki, Finland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Time frame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Time frame: At Enrolment Visit (Day 1) and at Day 1 of each PCR-confirmed recurrence
Time frame: At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24
Time frame: At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24
Time frame: Throughout the study period (from Day 1 up to Month 24)
Time frame: At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
Time frame: At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
Time frame: Throughout the study period (from Day 1 up to Month 24)
Time frame: Throughout the study period (from Day 1 up to Month 24)
GlaxoSmithKline
Industry
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.
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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