PHASE II, RANDOMIZED, DOUBLE-BLIND STUDY OF THE SAFETY AND EFFICACY OF SCH 41

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 具体目标 首要目标 为了评估三个剂量水平的SCH 417690在14天内的病毒学活性，这些患者感染了艾滋病毒，接受过治疗，但目前的利托那韦抗逆转录病毒疗法失败了。 次要目标 评估SCH 417690的长期安全性和耐受性。 [目的]评价三种剂量的SCH 417690在24周和48周的病毒学活性，并在基线基因型别和表型试验的基础上优化含有利托那韦的背景抗逆转录病毒方案。 [目的]评估筛查患者人群中基线的辅受体趋向性表型，服用SCH 417690的受试者中辅受体表型的变化(即从仅检测CCR5病毒到检测CCR5/CXCR4或仅检测CXCR4病毒)，以及作为少数准物种的X4病毒株的存在是否影响对SCH 417690的病毒学应答。 [目的]探讨SCH 417690的易感性变化和抗逆转录病毒治疗的背景，以及经历病毒学失败的接受SCH 417690的受试者病毒适合性的变化。 [目的]探讨过去和/或现在使用环境肽对接受SCH 417690治疗的受试者的病毒学应答的影响。 [目的]评价SCH 417690在24周和48周的免疫活性，以及优化的利托那韦抗逆转录病毒治疗方案。 [目的]探讨SCH 417690对免疫系统应答和临床感染性疾病发生率的影响。 [目的]探讨第14天和第8周的SCH 417690浓度与第4周和第24周(或更早的药物终止试验)的病毒学应答之间的关系。 [目的]探讨抗逆转录病毒药物与SCH 417690的依从性与病毒学应答的关系。

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. SPECIFIC AIMS Primary Objective To evaluate the virologic activity over 14 days of three dose levels of SCH 417690 in HIV-infected, treatment-experienced subjects who are failing their current ritonavir-containing antiretroviral regimen. Secondary Objectives ¿ To assess the longer-term safety and tolerability of SCH 417690. ¿ To evaluate the virologic activity at 24 and 48 weeks of three doses of SCH 417690 together with a background ritonavir-containing antiretroviral regimen optimized on the basis of baseline genotypic and phenotypic testing. ¿ To assess baseline coreceptor tropism phenotype in the screening patient population, changes in coreceptor phenotype (i.e., from detection of CCR5-only virus to detection of CCR5/CXCR4 or to CXCR4-only virus) in subjects taking SCH 417690, and whether the presence of X4 viral strains as a minority quasi-species influences the virologic response to SCH 417690. ¿ To explore change in susceptibility to SCH 417690 and the background antiretroviral regimen, and changes in viral fitness in subjects receiving SCH 417690 who experience virologic failure. ¿ To explore the effect of past and/or current enfuvirtide use on virologic response in subjects receiving SCH 417690. ¿ To evaluate the immunologic activity at 24 and 48 weeks of SCH 417690 together with an optimized background ritonavir-containing antiretroviral regimen. ¿ To explore the effects of SCH 417690 on immune system responses and the incidence of clinical infectious diseases. ¿ To explore the relationship of SCH 417690 concentrations at Day 14 and Week 8 to virologic response at Week 4 and at Week 24 (or earlier study drug termination), respectively. ¿ To explore the relationship of adherence with SCH 417690 and background antiretrovirals to virologic response.