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: 6115204
• 负责人: STEPHEN K TYRING
• 金额: $ 3.42万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6115204
• 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 patietns 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.

伐昔洛韦 1.5 克 BID 对于治疗 18 岁及以上免疫功能正常患者的局部带状疱疹是安全有效的。 这是一项开放标签单中心试验，旨在确定伐昔洛韦 1.5 克 BID 治疗 18 岁及以上免疫功能正常患者的单纯性带状疱疹的有效性和安全性。 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、生活质量和资源使用情况。 将通过监测临床化学和血液学以及报告不良事件（AE）来评估安全性。 慢性带状疱疹相关疼痛在 50 岁以上的患者中更为常见。 这些患者将被随访 24 周，因为大多数接受抗病毒治疗的患者将在第 24 周时不再出现带状疱疹并发症。