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

Condition(s) targeted: Herpes Zoster; Shingles

Intervention: valacyclovir (Drug); FV-100 (Drug); FV-100 (Drug); Valacyclovir placebo (Drug); FV-100 placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Inhibitex

Overall contact:
Eric Wenzel, BS, Phone: 678-746-1129, Email: ewenzel@inhibitex.com

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

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir in Patients With Herpes Zoster

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Herpes zoster associated pain, as measured by the Zoster Brief Pain Inventory (ZBPI)

Secondary outcome:

Herpes zoster associated pain

Herpes zoster lesion healing

Routine clinical labs

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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)

Eric Wenzel, BS, Phone: 678-746-1129, Email: ewenzel@inhibitex.com

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Vicki Barron, Phone: 205-975-6440
John W Gnann, Jr., MD, Principal Investigator

Quality of Life Medical & Research Center, LLC, Tucson, Arizona 85712, United States; Recruiting
Yvonne De Los Reyes, Phone: 520-733-2250
John "Jack" W McGettigan, Jr., MD, CCD, CPI, Principal Investigator

Paradigm Clinical, Inc., Tucson, Arizona 85705, United States; Recruiting
Kim Tschida, Phone: 520-829-6675
Pam Laubscher, DO, Principal Investigator

Westlake Medical Research, Westlake Village, California 913161, United States; Recruiting
Lyn Rideauz, RN, Phone: 805-496-3322
Edward Portnoy, MD, Principal Investigator

Solano Clinical Research, Vallejo, California 94589, United States; Recruiting
Taiwo Akande, Phone: 707-556-1107, Ext: 234
Serena Mraz, MD, Principal Investigator

Harmony Clinical, Inc., San Ramon, California 94583, United States; Recruiting
Kelli Davis, Phone: 925-413-1551
Stephen E Pratt, MD, Principal Investigator

California Research Foundation, San Diego, California 92103-6204, United States; Recruiting
Lorraine Boggs, Phone: 619-291-2321
Donald M. Brandon, MD, Principal Investigator

Lynn Institute of Pueblo, Pueblo, Colorado 81001, United States; Recruiting
Elissa Harrington, Phone: 719-542-9331
Rochelle Elijah, MD, Principal Investigator

Lynn Institute of the Rockies, Colorado Springs, Colorado 80909, United States; Recruiting
Patricia Wirtemburg, Phone: 719-636-3784
David Bird, MD, Principal Investigator

University of Colorado, Denver, Aurora, Colorado 80045, United States; Recruiting
Nancy Lang, Phone: 303-724-2454
Myron J Levin, MD, Principal Investigator

Mountain View Clinical Research, Denver, Colorado 80209, United States; Recruiting
Kristen Johnson, Phone: 720-941-9363
Richard Patt, MD, Principal Investigator

Belleair Research Center, Pinellas Park, Florida 33781, United States; Recruiting
Hue K Luong, CRC, Phone: 727-828-3353
Gary L. Heller, DO, Principal Investigator

Westside Center for Clinical Research, Jacksonville, Florida 32205, United States; Recruiting
Jeff Viau, RN, Phone: 904-693-1490
Mark A Stich, DO, Principal Investigator

Tampa Medical Group, Tampa, Florida 33614, United States; Recruiting
Tori Alpuin, Phone: 813-875-9742
Joel C Silverfield, MD, Principal Investigator

Lovelace Scientific Resources, Inc., Venice, Florida 34292, United States; Recruiting
Mandy Burdine, MA, Phone: 941-485-8314
Armando Navarro, MD, Principal Investigator

Florida Clinical Research Center, LLC, Fruitland Park, Florida 34731, United States; Recruiting
Lynda Smith, CCRC, Phone: 352-326-5600
Kalpana P Desai, MD, Principal Investigator

Springfield Clinic, Springfield, Illinois 62703, United States; Recruiting
Justin Roth, BS, CCRP, Phone: 217-528-7541, Ext: 4669
Randy Western, MD, Principal Investigator

Christie Clinic, Champaign, Illinois 61820, United States; Recruiting
Paula Phillips, RN, CRC, Phone: 217-366-1327
Lester Fahrner, MD, Principal Investigator

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana 46256, United States; Recruiting
Kathy Byrd, RN, Phone: 317-621-7731, Ext: 123
Kenneth W Dawes, MD, Principal Investigator

Deaconess Clinic - North, Evansville, Indiana 47710, United States; Recruiting
Amber Rice, Phone: 812-426-9574
James E Gutmann, MD, Principal Investigator

Deaconess Clinic Gateway Health Center, Newburgh, Indiana 47630, United States; Recruiting
Melissa Goffinet, Phone: 812-492-5011
Gary P Erdy, MD, Principal Investigator

Ireland Road Medical Group, South Bend, Indiana 46614, United States; Recruiting
Diane Messana, RN, Phone: 574-647-7883
Jerome R Skelly, MD, Principal Investigator

Trover Health System Center for Clinical Studies, Madisonville, Kentucky 42431, United States; Recruiting
Wilma Tapp, RN, Phone: 270-825-6678
Forrest Hanke, MD, Principal Investigator

Centennial Medical Group, Elkridge, Maryland 21075, United States; Recruiting
Kimberly S Moore, CCRC, Phone: 410-730-3399, Ext: 126
Walter Y Chi, MD, Principal Investigator

Clinical Associates, Reisterstown, Maryland 21136, United States; Recruiting
Mindy Davis, CRC, Phone: 410-526-3032
Claudio A Levin, MD, Principal Investigator

Washington University, St Louis, Missouri 64141, United States; Recruiting
Mary Tabacchi, Phone: 314-362-8171
Ann G Martin, MD, Principal Investigator

Health Care Research, Florissant, Missouri 63031, United States; Recruiting
Brian Springer, Phone: 314-972-9600
Larry D Reed, PhD, MD, Principal Investigator

Academic Dermatology Associates, Albuquerque, New Mexico 87106, United States; Recruiting
Ericka Maldonado, CCRC, Phone: 505-247-4220
Eduardo Tschen, MD, MBA, Principal Investigator

United Medical Associates, Endicott, New York 13760, United States; Recruiting
Lori Campbell, LPN, CCRC, Phone: 607-798-7345
Peter J LoFaso, Jr., MD, Principal Investigator

Triad Clinical Trials, LLC, Greensboro, North Carolina 27410, United States; Recruiting
Jill Kelly, RMA, CRC, Phone: 336-235-0991
Enrico G Jones, MD, Principal Investigator

Crescent Medical Research, Salisbury, North Carolina 28144, United States; Recruiting
Rene Lambert, Phone: 704-647-9913
Robert E McNeill, MD, Principal Investigator

Wilmington Medical Research, Wilmington, North Carolina 28401, United States; Recruiting
Marjorie Hall, Phone: 910-815-6108
Brian R Webster, MD, Principal Investigator

Durham VA Medical Center, Durham, North Carolina 27705, United States; Recruiting
Susan Doyle, LPN, Phone: 919-286-0411, Ext: 7265
Kenneth E Schmader, MD, Principal Investigator

Odyssey Research, Bismark, North Dakota 58501, United States; Recruiting
Laurie Holverson, Phone: 701-250-8416
Guy Tangedahl, MD, Principal Investigator

Hightop Medical Research Center, Cincinatti, Ohio 45224, United States; Recruiting
Linda S Fidelholtz, RN, Phone: 513-681-0606
James I Fidelholtz, MD, Principal Investigator

Providence Health Partners - Center for Clinical Research, Dayton, Ohio 45439, United States; Recruiting
Leslie Garrett, CCRC, Phone: 937-297-8578
Paul A Martin, DO, Principal Investigator

Medical Frontiers, LLC, Carlisle, Ohio 45005, United States; Recruiting
Teresa Campbell, Phone: 937-694-3520
Jewel A Stevens, MD, Principal Investigator

Dayton Clinical Research, Dayton, Ohio 45406, United States; Recruiting
Missy Chapman, Phone: 937-276-4311
Martin J Schear, MD, Principal Investigator

Lynn Institute of Norman (LION Research), Norman, Oklahoma 73069, United States; Recruiting
Karen Hames, Phone: 405-701-2466
Lisa Connery, MD, Principal Investigator

Westover Heights Clinic, Portland, Oregon 97210, United States; Recruiting
Karen Torres, Phone: 503-226-6678
Mary Meyer, MD, Principal Investigator

Oregon Health & Science University, Dept of Dermatology, Portland, Oregon 97239, United States; Recruiting
Shahana Baig-Lewis, MPH, Phone: 503-494-4770
Jon M Hanifin, MD, Principal Investigator

Harleysville Medical Associates, Harleysville, Pennsylvania 19438, United States; Recruiting
Janet Lorraine, RN, MSN, Phone: 215-256-9531
Richard S Lorraine, MD, Principal Investigator

Elite Medical Research, Sellersville, Pennsylvania 18960, United States; Recruiting
Donna Osborn, RN, CCRC, Phone: 215-257-8004
Kevin G Reinold, MD, Principal Investigator

Guthrie Clinic, Ltd., Sayre, Pennsylvania 18840, United States; Recruiting
Irmgard Lewis, CCRP, Phone: 570-882-6072
Michael Gehman, DO, Principal Investigator

Family Practice Medical Associates South, Jefferson Hills, Pennsylvania 15025, United States; Recruiting
Bobby Poyle, Phone: 412-729-1455
Daniel J Crable, MD, Principal Investigator

Palmetto Medical Research, Mount Pleasant, South Carolina 29464, United States; Recruiting
Jessica Collins, Phone: 843-849-1880
Richard E Mills, MD, Principal Investigator

Sanford Research / USD, Sioux Falls, South Dakota 57104, United States; Recruiting
Jennifer Meier, Phone: 605-328-1389
Jeffrey Jenkins, MD, Principal Investigator

TriCities Medical Research, Bristol, Tennessee 37620, United States; Recruiting
Chasity Monk, Phone: 423-989-3105
Frederick A Martin, MD, Principal Investigator

Holston Medical Group, Kingsport, Tennessee 37660, United States; Recruiting
Donna L Sturm, LPN, CCRC, Phone: 423-857-2787
Emily J Morawski, MD, Principal Investigator

Center for Clinical Studies, Houston, Texas 77030, United States; Recruiting
Natalia Mendoza, MD, Phone: 713-528-8818
Stephen Tyring, MD, PhD, Principal Investigator

Center for Clinical Studies - Clear Lake, Webster, Texas 77598, United States; Recruiting
Anita Satyaprakash, MD, Phone: 281-333-2288
Patricia Lee, MD, Principal Investigator

Oakwell Clinical Research, LLC, San Antonio, Texas 78218, United States; Recruiting
Janet Garza, RN, CRC, Phone: 210-477-1151
Melissa Kempf, MD, Principal Investigator

Arlington Research Center, Inc., Arlington, Texas 76011, United States; Recruiting
Alicia Soulivong, Phone: 682-365-3602
Angela Moore, MD, Principal Investigator

Scott & White Killeen Clinic, Killeen, Texas 76543, United States; Recruiting
Lydia Clipper, RNC, Phone: 254-680-1330
Mike Averitt, MD, Principal Investigator

Health Research of Hampton Roads, Newport News, Virginia 23606, United States; Recruiting
Holly LaPerriere, CCRC, Phone: 757-591-8100
Chester L Fisher, MD, MPH, Principal Investigator

Amherst Family Practice, Winchester, Virginia 22601, United States; Recruiting
Sarah Gray, RN, CDE, Phone: 540-504-0531
Patricia Houser, MD, Principal Investigator

Wenatchee Valley Medical Center, Wenatchee, Washington 98801, United States; Recruiting
Jannette A Smith, CMA, CRC, Phone: 509-665-5800
Steven R Kaster, MD, CPI, Principal Investigator

Starting date: May 2009
Last updated: October 13, 2009