Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Center for Research Resources (NCRR)
Collaborator:
University of Texas
Treatments:
Valacyclovir
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