RS79070 VERSUS IV GANCICLOVIR AS INDUCTION THERAPY FOR NEWLY DIAGNOSED CMV

RS79070 对比 IV 更昔洛韦作为新诊断 CMV 的诱导治疗

• 批准号: 6115788
• 负责人: DOROTHY Nahm FRIEDBERG
• 金额: $ 2.1万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6115788
• 关键词: Herpesviridae disease; clinical research; cytomegalovirus; ganciclovir; human subject; human therapy evaluation; intravenous administration; microorganism disease chemotherapy; retinitis

This randomized controlled comparison of the safety and efficacy of RS-79070, an oral pro-drug of ganciclovir with IV ganciclovir as induction therapy for the treatment of newly diagnosed peripheral CMV retinitis. Further objectives are to assess the effects of both induction and maintenance therapy with RS-79070 on CMV viral load, and to assess the pharmacokinetics of ganciclovir following administration of RS-79070. Patients will be randomly assigned to receive either IV ganciclovir at 5 mg/kg IV bid for 3 weeks, then IV ganciclovir 5mg/kg qd for one week. The other group will receive the investigational therapy of 900 mg of RS-79070 po bid for 3 weeks, followed by 900 mg of RS- 79070 qd for one week. Following this phase of the trial, all patients will be offered entry into a long-term follow-up phase of the study where they can receive 900 mg of RS-79070 po qd.

本随机对照比较RS-79070（更昔洛韦的口服前体药物）与IV更昔洛韦作为诱导疗法治疗新诊断的外周CMV视网膜炎的安全性和有效性。进一步的目的是评估RS-79070诱导和维持治疗对CMV病毒载量的影响，并评估RS-79070给药后更昔洛韦的药代动力学。患者将被随机分配接受IV更昔洛韦5 mg/kg IV bid，持续3周，然后IV更昔洛韦5 mg/kg qd，持续1周。 另一组将接受研究治疗，即900 mg RS-79070 po bid，持续3周，随后900 mg RS- 79070 qd，持续1周。在该试验阶段后，所有患者将进入研究的长期随访阶段，在此阶段，他们可以接受900 mg RS-79070 po qd。