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.

Completed

Conditions studied: Herpes Genitalis

In brief

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.

Key facts

Study ID

NCT04950712

Run by

GlaxoSmithKline

People needed

537

Starts

2021-06-09

Expected to finish

2024-03-14

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• 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 — Long Beach, California, United States

Full record on ClinicalTrials.gov

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