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

单克隆抗体CMV视网膜炎试验的主要目的是比较人抗CMV单克隆抗体（MSL 109）加活性药物主要治疗与匹配的安慰剂加活性药物主要治疗对AIDS患者新诊断和复发的CMV视网膜炎的安全性和疗效。325例患者试验将采用两阶段成组序贯设计，其中第一阶段入组和评价的76例患者的结果将触发政策和数据监测委员会的审查，以确定是否按计划进行全面招募目标、修改试验或终止试验。第一阶段的设计变量是CMV病毒负荷的变化和视网膜炎进展的时间。整个试验的设计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、视力变化和视野变化。

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.