Trial record 4 of 231 for:    "Herpes Zoster" [DISEASE]

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00900783
First received: May 12, 2009
Last updated: April 3, 2013
Last verified: April 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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 ]

Enrollment: 350
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00900783     History of Changes
Other Study ID Numbers: INH-FV1-005, INH-FV1-005-PK, INH-FV1-005-VR, INH-FV1-AGE
Study First Received: May 12, 2009
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
herpes zoster
shingles
Phase II
FV-100
Inhibitex

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014