ABT 606 VS ACYCLOVIR FOR TREATMENT OF HERPES ZOSTER

待检验的假设是 ABT-606 在治疗水痘带状疱疹病毒感染方面具有潜在应用。 这是一项阳性对照、双盲、双模拟、随机、四组、平行、多中心临床试验，受试者为 50 岁及以上患有活动性无并发症带状疱疹感染的患者。 为了符合资格，患者必须在出现带状疱疹样皮疹/水疱后 72 小时内登记。 研究分为两个时期；急性评估期（第 1-28 天）和随访期（第 29 天-研究结束）。 大约 400 名满足入组标准的患者将以平衡的方式进行随机分配，以便每个治疗组有 100 名患者被随机分配。 预计每个站点将招募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可能是阿昔洛韦治疗带状疱疹的有效且安全的替代品。

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.