A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster - Full Text View

Sponsor:	Inhibitex
Information provided by:	Inhibitex
ClinicalTrials.gov Identifier:	NCT00900783

Purpose

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

Condition	Intervention	Phase
Herpes Zoster Shingles	Drug: valacyclovir Drug: FV-100 Drug: Valacyclovir placebo Drug: FV-100 placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir in Patients With Herpes Zoster

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by Inhibitex:

Primary Outcome Measures:

Herpes zoster associated pain, as measured by the Zoster Brief Pain Inventory (ZBPI) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Herpes zoster associated pain [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Herpes zoster lesion healing [ Time Frame: Until healed ] [ Designated as safety issue: No ]
Routine clinical labs [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	350
Study Start Date:	May 2009

Arms	Assigned Interventions
1: Experimental FV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days	Drug: FV-100 200 mg, once daily, for seven days Drug: Valacyclovir placebo three times a day, for seven days
2: Experimental FV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days	Drug: FV-100 400 mg, once daily, for seven days Drug: Valacyclovir placebo three times a day, for seven days
3: Active Comparator Valacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days	Drug: valacyclovir 1 gram, three times a day for seven days Drug: FV-100 placebo once daily, for seven days

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Patients taking CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, telithromycin) or strong CYP3A4 inducers (e.g., rifampin, carbamazepine)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900783

Contacts

Contact: Eric Wenzel, BS	678-746-1129	ewenzel@inhibitex.com
Contact: Amy Morris, BS, MBA	678-746-1106	amorris@inhibitex.com

Show 62 Study Locations

Sponsors and Collaborators

Inhibitex

More Information

No publications provided

Responsible Party:	Inhibitex, Inc. ( Amy Morris / VP Clinical Development and Regulatory Affairs )
Study ID Numbers:	INH-FV1-005
Study First Received:	May 12, 2009
Last Updated:	December 18, 2009
ClinicalTrials.gov Identifier:	NCT00900783 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inhibitex:

herpes zoster
shingles
Phase II
FV-100
Inhibitex

Additional relevant MeSH terms:

Valacyclovir
Virus Diseases
Herpes Zoster
Anti-Infective Agents
Acyclovir

Therapeutic Uses
DNA Virus Infections
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010