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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02412917
• Other study ID #: CTRV-FV-2-007
• Status: Terminated
• Phase: Phase 3
• First received: March 23, 2015
• Last updated: December 20, 2017
• Start date: June 2015
• Est. completion date: November 2017

Study information

• Verified date: December 2017
• Source: ContraVir Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 237
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia
• Shingles

Intervention

Drug:
• FV-100
antiviral nucleoside analog
• valacyclovir
antiviral nucleoside analog

Locations

Country	Name	City	State
United States	TX	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ContraVir Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)	efficacy measure	Day 1 to Day 120
Secondary	The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir	efficacy measure	Day 1 to Day 120
Secondary	The number and classification of adverse events in 2 dosing regimens of FV-100	Safety measure	Day 1 to Day 120
Secondary	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