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.
NCT ID: NCT04950712
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
537 participants
OBSERVATIONAL
2021-06-09
2024-03-14
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Blood sampling
Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).
Anogenital lesion swab collection
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.
Interventions
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Blood sampling
Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).
Anogenital lesion swab collection
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Plantation, Florida, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Smyrna, Georgia, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Lawrenceville, New Jersey, United States
GSK Investigational Site
Newark, New Jersey, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Memphis, Tennessee, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Helsinki, , Finland
GSK Investigational Site
Oulu, , Finland
GSK Investigational Site
Tampere, , Finland
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Pierre-Bénite, , France
GSK Investigational Site
Saint-Etienne, , France
GSK Investigational Site
Toulouse, , France
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Bari, , Italy
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Milan, , Italy
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Palermo, , Italy
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Roma, , Italy
GSK Investigational Site
Alcorcón, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Marbella, , Spain
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Oviedo, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Birmingham, , United Kingdom
GSK Investigational Site
Brighton, , United Kingdom
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Leeds Yorkshire, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Southampton, , United Kingdom
Countries
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Other Identifiers
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214523
Identifier Type: -
Identifier Source: org_study_id
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