Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster

Herpes Zoster Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006131
• Other study ID #: 199/15324
• Secondary ID: UTMB-97-120GW-R-
• Status: Completed
• Phase: N/A
• First received: August 3, 2000
• Last updated: May 22, 2007
• Start date: January 1997

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Zoster
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Valacyclovir

Locations

Country	Name	City	State
United States	Center for Clinical Studies	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of Texas

Country where clinical trial is conducted

United States,