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.
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.Condition: – Herpes Zoster- Immunologic Deficiency Syndromes Study Type: InterventionalStudy Design: Treatment, Randomized, Double-Blind Further Study Details: 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. Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria PROTOCOL ENTRY CRITERIA:–Disease Characteristics–Patients with a clinical diagnosis of uncomplicated herpes zoster presenting within 72 hours after onset of zoster rashNo 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 transplantationSurgery: Greater than 9 months since prior liver or heart transplantationOther: 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 normalRenal: Creatinine clearance at least 30 mL/minOther: 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 Expected Total Enrollment: 66  Stephen K. Tyring, Study Chair, University of Texas
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