Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster
Information source: National Center for Research Resources (NCRR)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Zoster; Immunologic Deficiency Syndromes
Intervention: Valacyclovir (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Stephen K. Tyring, Study Chair, Affiliation: University of Texas
Summary
OBJECTIVES:
I. Compare the efficacy and safety of two doses of oral valacyclovir in immunocompromised
patients with uncomplicated herpes zoster.
II. Compare quality of life, pain, and medical resource utilization in patients treated with
these 2 regimens.
Clinical Details
Study design: Treatment, Randomized, Double-Blind
Detailed description:
PROTOCOL OUTLINE:
This is a randomized, double blind study.
Patients are randomized to one of two treatment arms.
Arm I: Patients receive standard dose oral valacyclovir three times a day on Days 1-7.
Arm II: Patients receive higher dose oral valacyclovir three times a day on Days 1-7.
Both arms: Patients begin treatment within 72 hours after onset of zoster rash.
Quality of life is assessed on Days 1, 14, and 28 during study and then every 4 weeks through
Week 24. Pain is assessed on Days 1-28 during study, and then weekly through Week 24. Medical
resource utilization is assessed on Days 1, 8, 14, and 18 during study and then every 4 weeks
through Week 24.
Patients are followed every 4 weeks through Week 24.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics--
Patients with a clinical diagnosis of uncomplicated herpes zoster presenting within 72
hours after onset of zoster rash
No evidence of cutaneous or visceral dissemination of herpes zoster infection; cutaneous
dissemination defined as at least 20 discrete lesions outside adjacent dermatomes
Must have immune dysfunction caused by any of the following: congenital immune deficiency;
active malignancy of any type; collagen vascular diseases; organ or bone marrow
transplantation; HIV infection; severe atopic dermatitis; received cytotoxic drugs or
immunosuppressive therapy (e. g., chronic systemic corticosteroids) within past 3 months
CD4 count at least 50%
- -Prior/Concurrent Therapy--
Biologic therapy: Greater than 9 months since prior bone marrow transplantation
Surgery: Greater than 9 months since prior liver or heart transplantation
Other: At least 4 weeks since prior topical or systemic anti-varicella zoster virus
(anti-VZV) medications; no concurrent systemic agents with anti-VZV activity from
enrollment to Day 10; no concurrent probenecid from 24 hours before the first dose of study
drug until Day 10
- -Patient Characteristics--
Hepatic: AST or ALT no greater than 5 times upper limit of normal
Renal: Creatinine clearance at least 30 mL/min
Other: Not pregnant or nursing; negative pregnancy test; fertile patients must use
effective contraception; no history of intolerance or hypersensitivity to acyclovir,
penciclovir, valacyclovir, or famciclovir
Locations and Contacts
Center for Clinical Studies, Houston, Texas 77058, United States
Additional Information
Starting date: January 1997
Last updated: May 22, 2007
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