VIROLOGIC RESPONSE TO NUCLEOSIDE REGIMENS AFTER PROLONGED ZDV OR DDI MONOTHERAPY

长期 ZDV 或 DDI 单药治疗后对核苷治疗方案的病毒学反应

• 批准号: 6290952
• 负责人: Kenneth H. Fife
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/6290952
• 关键词: 2'3' dideoxyinosine; AIDS therapy; clinical research; clinical trials; combination chemotherapy; drug screening /evaluation; human subject; human therapy evaluation; lamivudine; nucleoside analog; reverse transcriptase inhibitors; stavudine; virus RNA; zidovudine

This is a randomized, double-blind clincal trial involving subjects with prolonged prior experience with ZDV of ddI monotherapy. Eligible subjects are participants in ACTG 175 whi remained on their initial assigned monotherapy until the end of follow-up in ACTG 175 (data collection closed of Feb.28,1995) and for any intervening period until entry into ACTG 302. This clinical trial comprises two sub-groups. One is for subjects who were assigned ZDV monotherapy in ACTG 175; these subjects will be randomized to receive eithe d4T monotherapy or the combination ot 3TC and ZDV, in a blinded manner. The other is for subjects who were assigned ddI monotherapy in ACTG 175; these subjects will be randomized to receive eithe the combination of ddI and ZDV or the combination of 3TC and ZDV, in a blinded manner. The primary outcome measure is change in HIV RNA copy number. The duration of study treatment is planned to be 48 weeks.

这是一项随机、双盲的临床试验，受试者包括 延长了DDI单一疗法ZDV的既往经验。符合条件的科目 ACTG 175的参与者是否仍处于初始分配状态 单一治疗直到ACTG 175的随访结束(数据收集 1995年2月28日关闭)和任何其间的期间，直至进入 ACTG 302。 这项临床试验包括两个亚组。一个是针对以下对象的 在ACTG 175中被分配ZDV单一疗法；这些受试者将被 随机接受d4T单一治疗或3TC和联合治疗 ZDV，盲目地。另一种是针对分配了DDI的受试者 ACTG 175中的单一疗法；这些受试者将被随机接受 无论是DDI和ZDV的组合还是3TC和ZDV的组合， 以一种盲目的方式。主要的结果衡量标准是艾滋病毒核糖核酸的变化 复印号。研究治疗计划为48周。