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

人抗 CMV 单克隆抗体 MSL 109 的 II/III 期试验

• 批准号: 6309649
• 负责人: BRUCE A BARRON
• 金额: $ 1.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309649
• 关键词: AIDS; clinical research; cytomegalovirus; drug adverse effect; human mortality; human subject; human therapy evaluation; immunotherapy; medical complication; monoclonal antibody; opportunistic infections; outcomes research; retinitis; visual fields; visual perception

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.

单抗CMV视网膜炎试验的主要目的是比较人类抗CMV单抗(MSL 109)加主动一次治疗与匹配的安慰剂加主动一次治疗对艾滋病患者初诊和复发CMV视网膜炎的安全性和有效性。325名患者试验将使用两阶段分组顺序设计，其中第一阶段登记和评估的76名患者的结果将触发政策和数据监测委员会的审查，以确定是按计划继续进行全面招募目标，修改试验，还是终止试验。第一阶段的设计变量是CMV病毒载量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时间。其他结果测量包括死亡率、不良事件、视力变化和视野变化。