PHASE II/III TRIAL OF HUMAN ANTI-CMV MONOCLONAL ANTIBODY MSL 109

单抗CMV视网膜炎试验的主要研究对象是 目的：比较人源性抗巨细胞病毒抗体的安全性和有效性 单抗(MSL 109)加主动一次治疗与 匹配的安慰剂加积极的初级治疗对这两个新诊断的患者 以及艾滋病患者复发的CMV视网膜炎。325例患者试验 将使用两阶段分组顺序设计，其中结果来自 在第一阶段登记和评估的76名患者将触发 审查政策和数据监测委员会，以确定是否 按计划继续执行完整的招聘目标，修改试验，或 终止审判。第一阶段的设计变量是变化的 在CMV中，病毒载量和视网膜病变进展的时间。设计 整个试验的变量是视网膜炎进展的时间。 其他结果衡量标准包括死亡率、不良事件、 视力和视野的改变。

The Monoclonal Antibody CMV Retinitis Trial has, as its primary objective, the comparison of the safety and efficacy of Human Anti-CMV Monoclonal Antibody (MSL 109) plus active primary treatment versus matched placebo plus active primary treatment for both newly diagnosed and relapsed CMV retinitis in patients with AIDS. The 325 patient trial will use a two-stage group sequential design in which the results from 76 patients enrolled and evaluated in the first stage will trigger a review of the Policy and Data Monitoring Board to determine whether to proceed to the full recruitment goal as planned, modify the trial, or terminate the trial. The design variables for the first stage are change in CMV virologic load and time to progression of retinitis. The design variable for the overall trial is time to progression of retinitis. Additional outcome measures include mortality, adverse events, change in visual acuity, and change in visual fields.