A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster
September 23, 2015 updated by: Bristol-Myers Squibb
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
350
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 2
FV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days
|
400 mg, once daily, for seven days
200 mg, once daily, for seven days
three times a day, for seven days
|
|
ACTIVE_COMPARATOR: 3
Valacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days
|
1 gram, three times a day for seven days
Other Names:
once daily, for seven days
|
|
EXPERIMENTAL: 1
FV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days
|
400 mg, once daily, for seven days
200 mg, once daily, for seven days
three times a day, for seven days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI)
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Herpes zoster associated pain
Time Frame: 90 days
|
90 days
|
|
Herpes zoster lesion healing
Time Frame: Until healed
|
Until healed
|
|
Routine clinical labs
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
May 12, 2009
First Submitted That Met QC Criteria
May 12, 2009
First Posted (ESTIMATE)
May 13, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 12, 2015
Last Update Submitted That Met QC Criteria
September 23, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INH-FV1-005
- INH-FV1-005-PK
- INH-FV1-005-VR
- INH-FV1-AGE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.