ABT 606 VS ACYCLOVIR FOR TREATMENT OF HERPES ZOSTER

ABT 606 与阿昔洛韦治疗带状疱疹的比较

• 批准号: 6413630
• 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/6413630
• 关键词: acyclovir; antiviral agents; clinical research; clinical trials; drug screening /evaluation; human middle age (35-64); human subject; human therapy evaluation; longitudinal human study; microorganism disease chemotherapy; shingles

The hypothesis to be tested is that ABT-606 has potential application in the treatment of VZV infections. This is a positive control, double-blind, double-dummy, randomized, four-arm, parallel, multicenter clinical trial in patients 50 years and older with active uncomplicated herpes zoster infection. To be eligible patients must enroll within 72 hours of the appearance of zosteriform rash/vesicles. The study is divided into two periods; the Acute Assessment Period (days 1-28) and the Follow-up Perod (days 29-end of study). Approximately 400 patients who satisfy the entry criteria will be randomized in a balanced fashion so that 100 patients are randomized to each treatment arm. It is expected that each site will enroll 2-10 patients. The total duration of the study is six months. The significance of this study is that ABT-606 may be an effective and safe alternative to acyclovir for the treatment of shingles.

要检验的假设是ABT-606在VZV感染的治疗中具有潜在的应用。 这是一项阳性对照，双盲，双重失误，随机，四臂，平行，多中心临床试验，50岁及50岁以上患有活跃的单纯疱疹带状疱疹感染。 要获得合格的患者，必须在出现皮疹/囊泡的72小时内注册。 该研究分为两个时期；急性评估期（第1-28天）和随访perod（第29天研究）。 大约有400名满足进入标准的患者将以平衡的方式随机分配，以便100例患者被随机分配到每个治疗臂。 预计每个部位将招募2-10名患者。 研究的总持续时间为六个月。 这项研究的意义在于，ABT-606可能是Acyclovir治疗带状疱疹的有效替代方法。