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

NCT02412917 | Terminated Phase 3 DMC

• 1 other identifier: CTRV-FV-2-007
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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).

Conditions

Shingles; Herpes Zoster; Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)

  Day 1 to Day 120

• The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir

  Day 1 to Day 120

• The number and classification of adverse events in 2 dosing regimens of FV-100

  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

  Day 1 to Day 120

Study Arms (3)

FV-100 400 mg QD

EXPERIMENTAL

FV-100 400mg QD

Drug: FV-100

FV-100 400mg BID

EXPERIMENTAL

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

Drug: FV-100

valacyclovir

ACTIVE COMPARATOR

valacyclovir 1000mg TID

Drug: valacyclovir

Interventions

FV-100 DRUG

antiviral nucleoside analog

Also known as: antiviral nucleoside analog

FV-100 400 mg QD; FV-100 400mg BID

valacyclovir DRUG

antiviral nucleoside analog

Also known as: valtrex

valacyclovir

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have multidermal or disseminated AHZ
• Have facial, ophthalmologic or oral manifestations
• Have received Zostavax

Sponsors & Collaborators

• ContraVir Pharmaceuticals, Inc.: lead

Study Sites (1)

TX

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic

Interventions

FV-100; Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John Sullivan-Bolyai

  CMO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 9, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

US (1)