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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项比较3种剂量SCH 417690与匹配安慰剂的II期、双盲、随机化临床试验，分为3个阶段：（1）42天筛选期;（2）14天双盲、随机化、安慰剂对照、添加治疗期，以评估SCH 417690的抗逆转录病毒活性;和（3）46周持续期，评估SCH 417690的长期安全性和耐受性。在筛选阶段，将发送血液样本进行HIV共受体嗜性分析以及基因型和表型检测，以评估耐药性。 120名年龄大于或等于18岁的HIV感染男性和女性; CD 4+细胞计数大于或等于50个细胞/mm 3;在筛选HIV-1 RNA分离物时检测到仅R5表型;在当前含利托那韦的（总剂量100-800 mg/天）抗逆转录病毒方案;入组研究前8周内当前方案稳定且至少一种3种或更多种药物抗逆转录病毒方案病毒学失败的受试者将入组。 主要疗效终点是log 10 HIV-1 RNA从基线至第14天的变化。次要终点包括安全性和耐受性、病毒学和免疫学结局、临床结局、药代动力学结局、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