Herpes Zoster, Postherpetic Neuralgia, Shingles
Conditions
Brief summary
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
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.
Interventions
DRUGFV-100
antiviral nucleoside analog
DRUGvalacyclovir
antiviral nucleoside analog
Sponsors
ContraVir Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir. | Day 1 to Day 120 | efficacy measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI) | Day 1 to Day 120 | efficacy measure |
| The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir | Day 1 to Day 120 | efficacy measure |
| The number and classification of adverse events in 2 dosing regimens of FV-100 | Day 1 to Day 120 | Safety measure |
| The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID | Day 1 to Day 120 | Pharmacokinetic |
Countries
United States
Outcome results
None listed