Trial record 25 of 473 for:    Shingles

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00900783
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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. 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 or disease Intervention/treatment Phase
Herpes Zoster Shingles Drug: valacyclovir Drug: FV-100 Drug: Valacyclovir placebo Drug: FV-100 placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir in Patients With Herpes Zoster
Study Start Date : May 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: 2
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

Active Comparator: 3
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
Other Name: Valtrex

Drug: FV-100 placebo
once daily, for seven days

Experimental: 1
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

Primary Outcome Measures :
  1. Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI) [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Herpes zoster associated pain [ Time Frame: 90 days ]
  2. Herpes zoster lesion healing [ Time Frame: Until healed ]
  3. Routine clinical labs [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT00900783     History of Changes
Other Study ID Numbers: INH-FV1-005
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015

Keywords provided by Bristol-Myers Squibb:
herpes zoster
Phase II

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents