VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPETENT PATIENTS

伐昔洛韦治疗免疫功能正常患者带状疱疹

• 批准号: 6413652
• 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: 2000
• 资助国家: 美国
• 起止时间: 2000-12-01 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6413652
• 关键词: acyclovir; adult human (21+); antiviral agents; chronic pain; clinical chemistry; clinical research; clinical trial phase I; drug adverse effect; drug screening /evaluation; hematology; human subject; human therapy evaluation; medical complication; microorganism disease chemotherapy; oral administration; prodrugs; quality of life; self help; sensory discrimination; shingles

Valacyclovir 1.5 gram BID is safe and effective for treatment of localized herpes zoster in immunocompetent patients 18 years of age and older. This is an open label single center trial to determine the efficacy and safety of valacyclovir 1.5 grams BID for the treatment of uncomplicated herpes zoster in immunocompetent patients 18 years of age and older. The total duration of the study in patients under 50 years of age is 4 weeks. Patients will be evaluated for pain, abnormal sensations, zoster complications, quality of life and resource use. Safety will be assessed by monitoring clinical chemistry and hematology and by reporting adverse experiences (AEs). Chronic zoster-associated pain is markedly more common in patients >50 years old. These patients will be followed for 24 weeks, as most patients on antiviral therapy will cease to experience complication of zoster by week 24.

Valacyclovir 1.5克出价可安全有效，可在18岁及以上的免疫能力患者中治疗局部疱疹。这是一项开放式标签单中心试验，可确定Valacyclovir 1.5克竞标的功效和安全性用于治疗18岁及以上的免疫能力患者中简单的疱疹带状疱疹。 50岁以下患者的研究总持续时间为4周。 将评估患者的疼痛，异常感觉，带状疱疹并发症，生活质量和资源的使用。 安全将通过监测临床化学和血液学以及报告不良经历（AES）来评估安全性。 在50岁> 50岁的患者中，慢性带状疱疹相关的疼痛更为常见。 这些患者将进行24周，因为大多数抗病毒疗法的患者将在第24周之前停止经历带状疱疹的并发症。