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

NCT ID: NCT00006131

Last Updated: 2007-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-01-31

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.

Conditions

Herpes Zoster; Immunologic Deficiency Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Valacyclovir

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: lead

Principal Investigators

Stephen K. Tyring

Role: STUDY_CHAIR

University of Texas

Locations

Center for Clinical Studies

Houston, Texas, United States

Countries

United States

Other Identifiers

UTMB-97-120

Identifier Type: -

Identifier Source: secondary_id

GW-R-24

Identifier Type: -

Identifier Source: secondary_id

UTMB-GCRC-D085

Identifier Type: -

Identifier Source: secondary_id

199/15324

Identifier Type: -

Identifier Source: org_study_id