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.

  • STATUS
    Recruiting
  • End date
    Nov 9, 2023
  • participants needed
    500
  • sponsor
    GlaxoSmithKline
Updated on 19 August 2021
western blot
HIV Vaccine
herpes simplex
herpes lesion
genital herpes

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.

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.

Details
Condition Herpes Simplex, Genital Herpes, Female Genital Diseases
Treatment blood sampling, Anogenital lesion swab collection
Clinical Study IdentifierNCT04950712
SponsorGlaxoSmithKline
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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