VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPROMISED PATIENTS

伐昔洛韦治疗免疫功能低下患者的带状疱疹

• 批准号: 6566714
• 负责人: STEPHEN K TYRING
• 金额: $ 27.93万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2002-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6566714
• 关键词: acyclovir; adult human (21+); blood chemistry; chronic pain; clinical research; clinical trial phase I; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; immunosuppression; longitudinal human study; medical complication; microorganism disease chemotherapy; oral administration; pharmacokinetics; prodrugs; quality of life; questionnaires; self help; sensory discrimination; shingles; valacyclovir

Valacyclovir is safe and effective for treatment of localized herpes zoster in immunocompromised patients 18 years of age and older. This is a randomized, double-blind, controlled trial comparing the efficacy and safety of two doses of oral valacyclovir HCl for the treatment of uncomplicated herpes zoster in immunocompromised patients 18 years of age and older. In order that 25 patients complete therapy and follow-up in each of the two treatment groups, 66 patients will be equally randomized to each of these two treatment groups. Administration of the first dose(day 1) of study drug must occur within 72 hours of zoster rash onset. Patients will receive 1000 mg or 2000 mg valacyclovir three times daily for 7 days. These drugs will be taken orally. Patients' participation will be for a total of 24 weeks. Patients will be seen and assessed for zoster-associated pain and/or abnormal sensations and zoster complications on days 1,3,6,8,10,14,21, and 28 and then every 4 weeks up to and including week 24. Responses to resource use and quality of life questions will be collected at intervals during the study. Safety will be monitored by means of routine hematological and biochemical assessments and reporting of adverse experiences.

伐昔洛韦对于治疗 18 岁及以上免疫功能低下患者的局部带状疱疹是安全有效的。 这是一项随机、双盲、对照试验，比较两种剂量的口服盐酸伐昔洛韦治疗 18 岁及以上免疫功能低下患者的单纯性带状疱疹的疗效和安全性。 为了使两个治疗组各有 25 名患者完成治疗和随访，将有 66 名患者平均随机分配到这两个治疗组。 研究药物的第一剂（第 1 天）给药必须在带状疱疹发作后 72 小时内进行。 患者将接受 1000 mg 或 2000 mg 伐昔洛韦，每日 3 次，持续 7 天。这些药物将口服。 患者的参与期总共为 24 周。 将在第 1、3、6、8、10、14、21 和 28 天检查患者并评估带状疱疹相关的疼痛和/或异常感觉以及带状疱疹并发症，然后每 4 周一次，直至第 24 周（包括第 24 周）。在研究期间将不时收集有关资源使用和生活质量的问题。 将通过常规血液学和生化评估以及不良经历报告来监测安全性。