Herpes ZosterPhase 2NCT00900783
A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster
A Phase 2 study testing valacyclovir and FV-100 in people with Herpes Zoster and Shingles, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent in cells infected with varicella zoster virus, the virus that causes shingles. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Herpes Zoster, Shingles
- What is being tested?
- valacyclovir and FV-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2010
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 50 years of age
- Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash
- Patients with zoster-related pain (ZBPI worst pain score > 0)
- Patients able to be enrolled into the study ≤ 72 hours from appearance of rash (i.e., lesions or vesicles)
- Patients providing written informed consent
- Patients who are able to complete all study visits per protocol
- Men and premenopausal women must agree to practice a barrier method of birth control plus the use of a spermicide for one month after the last dose of study drug (oral contraceptives are not permitted)
Who cannot join
- Women who are pregnant or lactating
- Patients with multidermatomal or disseminated HZ (i.e., > 20 vesicles beyond the dermatomes adjacent to the primarily involved dermatome)
- Patients with HZ ophthalmicus, defined as cutaneous lesions in the dermatome associated with the ophthalmic division of the trigeminal nerve
- Patients with history of impaired renal function, (e.g., calculated creatinine clearance <50 mL/min/1.73 m2)
- Patients taking narcotic analgesic routinely for a chronic pain condition
- Patients taking tricyclic antidepressants
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- Patients who have received systemic antivirals with activity against VZV within the past 30 days, or a topical antiviral to treat their current HZ
- Patients who are immunosuppressed from:
- disease (e.g., malignancy [present or remission < 5 years], HIV)
- corticosteroid use (except intermittent or topical/inhaled beclomethasone dipropionate or equivalent < 800 mcg/day), or
- other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation)
- Patients with gastrointestinal dysfunction that could interfere with drug absorption
- Patients with any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment) that, in the opinion of the site investigator, might interfere with the evaluations required by the study
- Patients who are not ambulatory (bed-ridden or homebound); hospitalized patients may be enrolled if they are ambulatory and able to complete the study requirements
- Patients with history of allergy to valacyclovir hydrochloride
- Patients unlikely to adhere to protocol follow-up
- 14. Subjects taking strong CYP3A4-inhibiting protease inhibitors (specifically including atazanavir, indinavir, nelfinavir, saquinavir, and ritonavir), strong CYP3A4 inhibitors (specifically including clarithromycin, itraconazole, ketoconazole, nefazodone, telithromycin) and all strong CYP3A4 inducers (specifically including rifampin, efavirenz, etravirine, phenobarbital, phenytoin, and carbamazepine)
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir in Patients With Herpes Zoster
The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent in cells infected with varicella zoster virus, the virus that causes shingles. The study objectives include:
- Compare the safety of FV-100 to valacyclovir
- Compare the effect of FV-100, as compared to valacyclovir, on shingles pain
- Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions
- Conditions
- Herpes Zoster, Shingles
- Being tested
- valacyclovir, FV-100, Valacyclovir placebo, FV-100 placebo
- Keywords
- herpes zoster, shingles, Phase II, FV-100, Inhibitex
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valacyclovirDrug
Also called Valtrex
1 gram, three times a day for seven days
FV-100Drug
400 mg, once daily, for seven days
FV-100Drug
200 mg, once daily, for seven days
Valacyclovir placeboDrug
three times a day, for seven days
FV-100 placeboDrug
once daily, for seven days
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | FV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days Receives: Drug: FV-100; Drug: Valacyclovir placebo |
| 3 | Active comparator | Valacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days Receives: Drug: valacyclovir; Drug: FV-100 placebo |
| 1 | Experimental | FV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days Receives: Drug: FV-100; Drug: Valacyclovir placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI)
Measured: 30 days
Secondary outcomes (3)
Herpes zoster associated pain
Measured: 90 days
Herpes zoster lesion healing
Measured: Until healed
Routine clinical labs
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900783
- Sponsor's protocol ID
- INH-FV1-005
- Other IDs
- INH-FV1-005-PK, INH-FV1-005-VR, INH-FV1-AGE
- Status last verified
- Sep 2015
- First submitted
- 12 May 2009
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tyring SK, Lee P, Hill GT Jr, Silverfield JC, Moore AY, Matkovits T, Sullivan-Bolyai J. FV-100 versus valacyclovir for the prevention of post-herpetic neuralgia and the treatment of acute herpes zoster-associated pain: A randomized-controlled trial. J Med Virol. 2017 Jul;89(7):1255-1264. doi: 10.1002/jmv.24750. Epub 2016 Dec 26.
PubMed 27943311
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir in Patients With Herpes Zoster
- ClinicalTrials.gov ID
- NCT00900783
- Acronym / sponsor ID
- INH-FV1-005
- Conditions
- Herpes Zoster, Shingles
- Keywords
- herpes zoster, shingles, Phase II, FV-100, Inhibitex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 May 2009 (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.
The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent in cells infected with varicella zoster virus, the virus that causes shingles. The study objectives include:
- Compare the safety of FV-100 to valacyclovir
- Compare the effect of FV-100, as compared to valacyclovir, on shingles pain
- Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: FV-100, Drug: Valacyclovir placeboFV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days |
| 3 | Active comparator | Drug: valacyclovir, Drug: FV-100 placeboValacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days |
| 1 | Experimental | Drug: FV-100, Drug: Valacyclovir placeboFV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥ 50 years of age
- Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash
- Patients with zoster-related pain (ZBPI worst pain score > 0)
- Patients able to be enrolled into the study ≤ 72 hours from appearance of rash (i.e., lesions or vesicles)
- Patients providing written informed consent
Key exclusion criteria (17 listed)
- Women who are pregnant or lactating
- Patients with multidermatomal or disseminated HZ (i.e., > 20 vesicles beyond the dermatomes adjacent to the primarily involved dermatome)
- Patients with HZ ophthalmicus, defined as cutaneous lesions in the dermatome associated with the ophthalmic division of the trigeminal nerve
- Patients with history of impaired renal function, (e.g., calculated creatinine clearance <50 mL/min/1.73 m2)
- Patients taking narcotic analgesic routinely for a chronic pain condition
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 |
|---|---|---|
| valacyclovirAlso: Valtrex1 gram, three times a day for seven days | Drug | 3 |
| FV-100400 mg, once daily, for seven days | Drug | 2 |
| FV-100200 mg, once daily, for seven days | Drug | 1 |
| Valacyclovir placebothree times a day, for seven days | Drug | 1, 2 |
| FV-100 placeboonce daily, for seven days | Drug | 3 |
Primary outcome
Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI)
Time frame: 30 days
3 secondary outcomes
Herpes zoster associated pain
Time frame: 90 days
Herpes zoster lesion healing
Time frame: Until healed
Routine clinical labs
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 27943311Tyring SK, Lee P, Hill GT Jr, Silverfield JC, Moore AY, Matkovits T, Sullivan-Bolyai J. FV-100 versus valacyclovir for the prevention of post-herpetic neuralgia and the treatment of acute herpes zoster-associated pain: A randomized-controlled trial. J Med Virol. 2017 Jul;89(7):1255-1264. doi: 10.1002/jmv.24750. Epub 2016 Dec 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing valacyclovir and FV-100 in people with Herpes Zoster and Shingles, run by Bristol-Myers Squibb.
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 7 inclusion and 17 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: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00900783, which also lists 1 linked publication.
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 12 Oct 2015.