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

NCT00006131 | Completed

• 4 other identifiers: 199/15324UTMB-97-120GW-R-24UTMB-GCRC-D085
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster; Immunologic Deficiency Syndromes

Interventions

Valacyclovir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• University of Texas: collaborator

Study Sites (1)

Center for Clinical Studies

Houston, Texas, 77058, United States

Location

MeSH Terms

Conditions

Herpes Zoster; Immunologic Deficiency Syndromes

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stephen K. Tyring

  University of Texas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: August 4, 2000
• Study Start: January 1, 1997
• Last Updated: May 24, 2007

Record last verified: 2003-12

Locations

US (1)