A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia

Study Overview
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Brief Summary
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This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).

Detailed Description
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This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster). Subjects diagnosed with uncomplicated AHZ within 72 hours of lesion appearance and worst pain of 4 or greater at day 1, will be randomized (1:1:1) to one of three treatment groups and will begin study treatment at the Day 1 visit(within 72 hours of AHZ lesion appearance) to either: 1. FV-100 400mg QD, 2. FV-100 400mg BID(total daily dose of 800mg), or 3. Valacyclovir 1000mg 3 times a day for a total daily dose of 3000mg. Subjects will be monitored for adverse events through day 21. Efficacy assessments for lesion status and AHZ pain are captured til day 120.

Official Title
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A Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster Associated Pain

Conditions
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Shingles, Herpes Zoster, Postherpetic Neuralgia

Intervention / Treatment
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* Drug: FV-100
* Drug: valacyclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash Have zoster-related pain Are able to be randomized and receive their first dose within approximately 120 hours from appearance of rash Exclusion Criteria: Have multidermal or disseminated AHZ Have facial, ophthalmologic or oral manifestations Have received Zostavax

Ages Eligible for Study
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Minimum Age: 30 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FV-100 400 mg QD<br>FV-100 400mg QD | Drug: FV-100<br>* antiviral nucleoside analog<br>* Other names: antiviral nucleoside analog;|
| Experimental: FV-100 400mg BID<br>FV-100 400mg BID(total daily dose of 800mg) | Drug: FV-100<br>* antiviral nucleoside analog<br>* Other names: antiviral nucleoside analog;|
| Active Comparator: valacyclovir<br>valacyclovir 1000mg TID | Drug: valacyclovir<br>* antiviral nucleoside analog<br>* Other names: valtrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir. | efficacy measure | Day 1 to Day 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI) | efficacy measure | Day 1 to Day 120 | 
| The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir | efficacy measure | Day 1 to Day 120 | 
| The number and classification of adverse events in 2 dosing regimens of FV-100 | Safety measure | Day 1 to Day 120 | 
| The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID | Pharmacokinetic | Day 1 to Day 120 |