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.

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Herpes Genitalis

Treatments: Procedure: Anogenital lesion swab collection; Procedure: Blood sampling

Study type: Observational

Funder types: Industry

Identifiers

NCT04950712

214523

Details and patient eligibility

About

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.

Enrollment: 537 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

537 participants in 1 patient group

Overall Study Group

Description:

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.

Treatment:

Procedure: Blood sampling

Procedure: Anogenital lesion swab collection