ShinglesPhase 3NCT02412917
A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia
A Phase 3 study testing FV-100 and valacyclovir in people with Shingles and Herpes Zoster, run by ContraVir Pharmaceuticals, Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Shingles, Herpes Zoster, Postherpetic Neuralgia
- What is being tested?
- FV-100 and valacyclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Nov 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have multidermal or disseminated AHZ
- Have facial, ophthalmologic or oral manifestations
- Have received Zostavax
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Shingles, Herpes Zoster, Postherpetic Neuralgia
- Being tested
- FV-100, valacyclovir
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FV-100Drug
Also called antiviral nucleoside analog
antiviral nucleoside analog
valacyclovirDrug
Also called valtrex
antiviral nucleoside analog
| Study group | Role | What they receive |
|---|---|---|
| FV-100 400 mg QD | Experimental | FV-100 400mg QD Receives: Drug: FV-100 |
| FV-100 400mg BID | Experimental | FV-100 400mg BID(total daily dose of 800mg) Receives: Drug: FV-100 |
| valacyclovir | Active comparator | valacyclovir 1000mg TID Receives: Drug: valacyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
efficacy measure
Measured: Day 1 to Day 120
Secondary outcomes (4)
Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)
efficacy measure
Measured: Day 1 to Day 120
The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir
efficacy measure
Measured: Day 1 to Day 120
The number and classification of adverse events in 2 dosing regimens of FV-100
Safety measure
Measured: 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
Measured: Day 1 to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShinglesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Sullivan-Bolyai, Study director, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412917
- Sponsor's protocol ID
- CTRV-FV-2-007
- Status last verified
- Dec 2017
- First submitted
- 23 Mar 2015
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02412917
- Acronym / sponsor ID
- CTRV-FV-2-007
- Conditions
- Shingles, Herpes Zoster, Postherpetic Neuralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 237 participants (actual)
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FV-100 400 mg QD | Experimental | Drug: FV-100FV-100 400mg QD |
| FV-100 400mg BID | Experimental | Drug: FV-100FV-100 400mg BID(total daily dose of 800mg) |
| valacyclovir | Active comparator | Drug: valacyclovirvalacyclovir 1000mg TID |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Have multidermal or disseminated AHZ
- Have facial, ophthalmologic or oral manifestations
- Have received Zostavax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FV-100Also: antiviral nucleoside analogantiviral nucleoside analog | Drug | FV-100 400 mg QD, FV-100 400mg BID |
| valacyclovirAlso: valtrexantiviral nucleoside analog | Drug | valacyclovir |
Primary outcome
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
Time frame: Day 1 to Day 120
efficacy measure
4 secondary outcomes
Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)
Time frame: Day 1 to Day 120
The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir
Time frame: Day 1 to Day 120
The number and classification of adverse events in 2 dosing regimens of FV-100
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
Time frame: Day 1 to Day 120
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
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Shingles
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Sullivan-Bolyai study director
CMO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FV-100 and valacyclovir in people with Shingles and Herpes Zoster, run by ContraVir Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir. (time frame: Day 1 to Day 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017; AzTrials last refreshed its copy on 31 Oct 2026.