A5211: AN ORALLY ADMINISTERED HIV-1 ENTRY INHIBITOR IN HIV TX EXPERIENCED PTS

A5211：一种口服 HIV-1 进入抑制剂，用于治疗 HIV TX 患者

• 批准号: 7378015
• 负责人: ROBERT C KALAYJIAN
• 金额: $ 1.42万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378015
• 关键词: A5211; ORALLY; ADMINISTERED; HIV; ENTRY

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase II, double-blind, randomized clinical trial of three doses of SCH 417690 vs. matching placebo with three phases: (1) 42-day screening phase; (2) 14-day double-blind, randomized, placebo-controlled, add-on phase to assess the antiretroviral activity of SCH 417690; and (3) 46-week continuation phase to assess the longer-term safety and tolerability of SCH 417690. During the screening phase a blood sample will be sent for analysis of HIV co-receptor tropism and genotypic and phenotypic testing to assess drug resistance. One hundred twenty HIV-infected men and women greater than or equal to 18 years of age; CD4+ cell count greater than or equal to 50 cells/mm3; R5-only phenotype detected on screening HIV-1 RNA isolate; HIV-1 RNA greater than or equal to 5000 copies/ml on a current ritonavir-containing (total dose 100-800 mg/day) antiretroviral regimen; current regimen stable for the 8 weeks prior to study entry and virologic failure on at least one 3 or more drug antiretroviral regimen will be enrolled. The primary efficacy endpoint is the change in log10 HIV-1RNA from baseline to day 14. Secondary endpoints include safety and tolerability, virologic and immunologic outcomes, clinical outcomes, pharmacokinetic outcomes, viral co-receptor phenotype and adherence

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。这是一项 II 期、双盲、随机临床试验，比较三种剂量的 SCH 417690 与匹配的安慰剂，分三个阶段：(1) 42 天筛选阶段； (2) 14天双盲、随机、安慰剂对照、附加阶段，以评估 SCH 417690 的抗逆转录病毒活性； (3) 46 周的持续阶段，以评估 SCH 417690 的长期安全性和耐受性。在筛选阶段，将发送血样进行 HIV 共受体向性分析以及基因型和表型测试，以评估耐药性。 120 名年龄大于或等于 18 岁的艾滋病毒感染者； CD4+细胞计数大于或等于50个细胞/mm3；在筛选 HIV-1 RNA 分离株时检测到仅 R5 表型；当前含利托那韦（总剂量 100-800 毫克/天）抗逆转录病毒治疗方案中 HIV-1 RNA 大于或等于 5000 拷贝/ml；目前的治疗方案在进入研究之前的 8 周内保持稳定，并且至少一种 3 种或更多药物抗逆转录病毒治疗方案的病毒学失败将被纳入。 主要疗效终点是 log10 HIV-1RNA 从基线到第 14 天的变化。次要终点包括安全性和耐受性、病毒学和免疫学结果、临床结果、药代动力学结果、病毒辅助受体表型和依从性