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

单克隆抗体CMV视网膜炎试验，作为其主要 目的比较人源抗巨细胞病毒（CMV）的安全性和有效性 单克隆抗体（MSL 109）加积极的一级治疗与 匹配的安慰剂+活性主要治疗， 和复发性CMV视网膜炎。325例患者试验 将采用两阶段成组序贯设计， 第一阶段入组和评价的76例患者将触发 审查政策和数据监测委员会，以确定是否 按计划完成招募目标，修改试验，或 终止试验。第一阶段的设计变量是变化 CMV病毒负荷和视网膜炎进展时间。设计 整个试验的变量是视网膜炎进展的时间。 其他结局指标包括死亡率、不良事件、 视力和视野的变化。

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.