NCT00006131已完成不适用
Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster
National Center for Research Resources (NCRR)2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 1997年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究者
研究点 (2)
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