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: 6117784
• 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/6117784
• 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、双盲临床试验，受试者 ZDV或ddI单药治疗的长期既往经验。 合格受试者 是ACTG 175的参与者， ACTG 175中的单药治疗直至随访结束（数据收集 1995年2月28日关闭），并在进入 第302章. 本临床试验包括两个亚组。 一种是针对那些 在ACTG 175中分配ZDV单药治疗;这些受试者将 随机接受d4 T单药治疗或3 TC和 ZDV，设盲。 另一种是分配了ddI的受试者 ACTG 175单药治疗;这些受试者将随机接受 ddI和ZDV的组合或3 TC和 ZDV， 以盲目的方式。 主要结果指标是HIV RNA的变化 副本编号。 研究治疗的持续时间计划为48周。