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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项II期双盲随机临床试验，试验分为三个阶段：(1)42天的筛选阶段；(2)14天的双盲、随机、安慰剂对照的添加阶段，以评估SCH 417690的抗逆转录病毒活性；(3)为期46周的持续阶段，以评估SCH 417690的长期安全性和耐受性。在筛查阶段，将送一份血液样本进行艾滋病毒共同受体趋向性分析以及基因和表型测试，以评估耐药性。120名感染艾滋病毒的男女大于或等于18岁；CD4细胞计数大于或等于50个/mm3；在筛查中检测到仅有R5表型的HIV-1 RNA分离物；在当前含有利托那韦(总剂量为100-800毫克/天)的抗逆转录病毒疗法中，HIV-1RNA大于或等于5000拷贝/毫升；在进入研究前的8周内目前的疗法是稳定的，并且病毒学失败的至少3种或更多的抗逆转录病毒疗法将被登记。主要疗效终点是从基线到第14天的log10 HIV-1RNA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、病毒共受体表型和依从性

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