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

ContraVir Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Postherpetic Neuralgia; Shingles; Herpes Zoster

Treatments: Drug: FV-100; Drug: valacyclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02412917

CTRV-FV-2-007

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 237 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

237 participants in 3 patient groups

FV-100 400 mg QD

Experimental group

Description:

FV-100 400mg QD

Treatment:

Drug: FV-100

FV-100 400mg BID

Experimental group

Description:

FV-100 400mg BID(total daily dose of 800mg)

Treatment:

Drug: FV-100

valacyclovir

Active Comparator group

Description:

valacyclovir 1000mg TID

Treatment:

Drug: valacyclovir