Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes

Study Overview
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Brief Summary
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The aim of the study is to evaluate the safety and efficacy of AIC316 (pritelivir) 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.

Detailed Description
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Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days.

Official Title
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A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of AIC316 (Pritelivir) 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults.

Conditions
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Genital Herpes

Intervention / Treatment
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* Drug: AIC316
* Drug: Valacyclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, immunocompetent men and women in good health of any ethnic group Seropositive for Herpes Simplex Virus Type 2 (HSV-2) History of recurrent episodes (>=4 to <=9) of genital herpes for at least 12 months and willingness to obtain 4 swabs per day. Exclusion Criteria: Present episode of genital herpes at time of randomization Clinically relevant acute or chronic infections (excluding HSV-2) Known intolerance to valacyclovir, acyclovir, or any component of the formulation Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIC316, Then Valacyclovir<br>Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days. | Drug: AIC316<br>* 100 mg oral administration<br>Drug: Valacyclovir<br>* 500 mg oral administration<br>|
| Active Comparator: Valacyclovir, Then AIC316<br>Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days. | Drug: AIC316<br>* 100 mg oral administration<br>Drug: Valacyclovir<br>* 500 mg oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-subject Genital HSV Mucocutaneous Shedding Rate | Subjects were assessed for within-subject genital HSV mucocutaneous shedding rate, as calculated by the number of HSV-positive swabs per subject relative to the total number of swabs collected per subject. The swab test detects the presence of herpes virus DNA. A swab was regarded as positive for HSV-DNA if at least 3 HSV genome copies were detected by quantitative PCR per reaction (equaling 150 copies per mL of swab collection medium). When multiple swabs were available from the same time point (e.g., genital and lesional swab), the swab with the highest copy number was retained for computation of the shedding rate. | 28 days | 
| Overall Shedding Rate | Subjects were assessed for overall shedding rate as the total number of HSV-positive swabs per treatment group divided by the number of swabs collected per treatment group. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIC316, Viral shedding