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A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster - NCT00900783-35294(Clinical Trial 365264)



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City:  Birmingham
State:  
AL
Zip Code: 35294
Conditions: Herpes Zoster - Shingles
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
Study summary:
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)
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Data Source: ClinicalTrials.gov
Date Processed: September 9, 2010
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