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

Phase 3TerminatedNCT02412917

ContraVir Pharmaceuticals, Inc.237 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

237

Conditions

Shingles Herpes Zoster Postherpetic Neuralgia

Interventions

FV-100DRUG

antiviral nucleoside analog

valacyclovirDRUG

antiviral nucleoside analog

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Webster, Texas, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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