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.

NCT04950712 | Completed

• 1 other identifier: 214523
• Study Type: observational
• Target: 537
• Locations: 6 countries
• Sites: 51

Brief 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.

Conditions

Herpes Genitalis

Keywords

Herpes Simplex Virus-2; HSV-2 genital herpes; HSV-2 recurrence

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)

Secondary Outcomes (14)

• Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of severity (PGI-S) questionnaire

  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

  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

  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

  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

  From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)

Study Arms (1)

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.

Procedure: Blood sampling; Procedure: Anogenital lesion swab collection

Interventions

Blood sampling PROCEDURE

Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).

Overall Study Group

Anogenital lesion swab collection PROCEDURE

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.

Overall Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited in specific community settings in the United States and in Europe. Screening logs will be used to assess participation rate.

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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (51)

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

San Francisco, California, 94102, United States

Location

GSK Investigational Site

Miami, Florida, 33015, United States

Location

GSK Investigational Site

Miami, Florida, 33126, United States

Location

GSK Investigational Site

Miami, Florida, 33134, United States

Location

GSK Investigational Site

Plantation, Florida, 33317, United States

Location

GSK Investigational Site

Marietta, Georgia, 30067, United States

Location

GSK Investigational Site

Smyrna, Georgia, 30082, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64111, United States

Location

GSK Investigational Site

St Louis, Missouri, 63108, United States

Location

GSK Investigational Site

Lawrenceville, New Jersey, 08648, United States

Location

GSK Investigational Site

Newark, New Jersey, 07103, United States

Location

GSK Investigational Site

Columbus, Ohio, 43213, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38129, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Houston, Texas, 77054, United States

Location

GSK Investigational Site

Houston, Texas, 77339, United States

Location

GSK Investigational Site

Richmond, Virginia, 23235, United States

Location

GSK Investigational Site

Helsinki, 00250, Finland

Location

GSK Investigational Site

Oulu, 90100, Finland

Location

GSK Investigational Site

Tampere, FI-33100, Finland

Location

GSK Investigational Site

Montpellier, 34295, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Paris, 75010, France

Location

GSK Investigational Site

Paris, 75679, France

Location

GSK Investigational Site

Pierre-Bénite, 69495, France

Location

GSK Investigational Site

Saint-Etienne, 42055, France

Location

GSK Investigational Site

Toulouse, 31059, France

Location

GSK Investigational Site

Bari, 70120, Italy

Location

GSK Investigational Site

Milan, 20127, Italy

Location

GSK Investigational Site

Palermo, 90127, Italy

Location

GSK Investigational Site

Roma, 00144, Italy

Location

GSK Investigational Site

Alcorcón, 28922, Spain

Location

GSK Investigational Site

Barcelona, 08001, Spain

Location

GSK Investigational Site

Madrid, 28010, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Marbella, 29600, Spain

Location

GSK Investigational Site

Oviedo, 33011, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

GSK Investigational Site

Birmingham, B4 6DH, United Kingdom

Location

GSK Investigational Site

Brighton, BN2 1ES, United Kingdom

Location

GSK Investigational Site

Leeds Yorkshire, LS2 8NG, United Kingdom

Location

GSK Investigational Site

Liverpool, L7 8YE, United Kingdom

Location

GSK Investigational Site

London, SE1 0UN, United Kingdom

Location

GSK Investigational Site

London, WC1E 6JB, United Kingdom

Location

GSK Investigational Site

Southampton, SO14 0YG, United Kingdom

Location

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 6, 2021
• Study Start: June 9, 2021
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7); ES (8); US (22); IT (4); FI (3); GB (7)