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.

Herpes Genitalis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04950712
• Other study ID #: 214523
• Status: Active, not recruiting
• Start date: June 9, 2021
• Est. completion date: April 9, 2024

Study information

• Verified date: February 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: April 9, 2024
• Est. primary completion date: April 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Herpes Genitalis
• Herpes Simplex

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Tampere
France	GSK Investigational Site	Montpellier cedex 5
France	GSK Investigational Site	Nantes Cedex 1
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Pierre Bénite
France	GSK Investigational Site	Saint Etienne Cedex 02
France	GSK Investigational Site	Toulouse Cedex 9
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Roma	Lazio
Spain	GSK Investigational Site	Alcorcon
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	GSK Investigational Site	Oviedo	Asturias
Spain	GSK Investigational Site	Valencia
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Brighton
United Kingdom	GSK Investigational Site	Leeds
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Southampton
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Kingwood	Texas
United States	GSK Investigational Site	Lawrenceville	New Jersey
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Memphis	Tennessee
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	Newark	New Jersey
United States	GSK Investigational Site	North Chesterfield	Virginia
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Smyrna	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Finland,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HOIQ questionnaire		From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Secondary	Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by EuroQoL-5 dimension (EQ-5D) health questionnaire		At Enrolment Visit (Day 1) and at Day 1 of each PCR-confirmed recurrence
Secondary	Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by Recurrent genital herpes quality-of-life (RGHQoL) questionnaire		At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24
Secondary	Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by short form-12 questionnaire		At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24
Secondary	Number of self-swabs collected during genital HSV-2 recurrences throughout the study period		Throughout the study period (from Day 1 up to Month 24)
Secondary	HSV-2 PCR self-swab results		At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
Secondary	HSV-2 PCR investigator swab results		At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
Secondary	Number of patients reporting genital HSV-2 recurrences by using eDiary		Throughout the study period (from Day 1 up to Month 24)
Secondary	Number of patients reporting genital HSV-2 recurrence during the 3 monthly calls with the investigator		Throughout the study period (from Day 1 up to Month 24)