Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes

Official Title
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A Randomized, Multicenter, Double-blind Study to Compare the Efficacy of Single-day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Immunocompetent Black Patients

Conditions
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Genital Herpes

Intervention / Treatment
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* Drug: Famciclovir
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Black men or women 18 years or older History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy Documented herpes simplex virus type 2 (HSV-2) seropositivity Willingness to discontinue suppressive therapy during study, if applicable Willingness and ability to comply with the study protocol Exclusion Criteria: Pregnant or breastfeeding women Women of childbearing potential not using accepted methods of contraception Hypersensitivity to famciclovir or drugs with similar chemical structures Renal dysfunction Known or suspected to have decompensated liver disease Known to have gastrointestinal malabsorption Known to be immunocompromised Known to be hypersensitive to ingredients in study medication Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Famciclovir 1000 mg; twice a day for one day. | Drug: Famciclovir<br>* oral; two 500 mg tablets twice a day; single day treatment<br>* Other names: Famvir;|
| Placebo Comparator: 2<br>Placebo; twice a day for one day. | Drug: Placebo<br>* oral; two tablets twice a day; single day treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions | Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present). | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period |  | 21 days | 
| Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | Kaplan-Meier estimation. | 21 days | 
| Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method. | 72 hour after initiation of study medication up to 21 days | 
| Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period | Number of participants with a second recurrence of genital herpes in the follow-up period. | 6 months | 
| Time to Second Recurrence of Genital Herpes | Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions. | 6 months | 
| The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. | Baseline, Day 2 | 
| The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase) | Baseline, Day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent genital herpes, Black population