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.

GlaxoSmithKline537 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

537

Conditions

Herpes Genitalis

Interventions

Blood samplingPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (51)

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

Outcomes

Primary Outcomes

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.

Time frame: 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).

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

Secondary Outcomes

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