search
Back to results

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

Primary Purpose

Herpes Zoster, Immunologic Deficiency Syndromes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Valacyclovir
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Clinical Studies

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
May 22, 2007
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Texas
search

1. Study Identification

Unique Protocol Identification Number
NCT00006131
Brief Title
Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Texas

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster, Immunologic Deficiency Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Valacyclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen K. Tyring
Organizational Affiliation
University of Texas
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs