A Phase 3 interventional study of FV-100 and valacyclovir in Shingles, Herpes Zoster and Postherpetic Neuralgia, sponsored by ContraVir Pharmaceuticals, Inc.. Terminated at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by ContraVir Pharmaceuticals, Inc. · Phase 3, Interventional, and Prevention
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).
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.
Exclusion Criteria:
FV-100 400mg QD
Drug: FV-100
FV-100 400mg BID(total daily dose of 800mg)
Drug: FV-100
valacyclovir 1000mg TID
Drug: valacyclovir
antiviral nucleoside analog
Also known as: antiviral nucleoside analog
antiviral nucleoside analog
Also known as: valtrex
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
efficacy measure
Time frame: Day 1 to Day 120
Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)
efficacy measure
Time frame: Day 1 to Day 120
The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir
efficacy measure
Time frame: Day 1 to Day 120
The number and classification of adverse events in 2 dosing regimens of FV-100
Safety measure
Time frame: 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
Time frame: Day 1 to Day 120
This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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ContraVir Pharmaceuticals, Inc.