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

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。本研究旨在评估研究药物SCH 417690（一种口服给药的HIV-1进入抑制剂）在HIV感染的、接受过治疗的受试者中的安全性和疗效。SCH 417690通过特异性阻断CCR 5共受体发挥作用。这项研究的目的是确定什么剂量是最有效的，并确定报告的副作用。受试者将被随机分配至4个治疗组之一，分为3个阶段：42天筛选期、14天添加期和46周持续期。在这项多中心研究中，将在全国范围内招募120例受试者，在当地招募10例受试者。

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 study is being conducted to assess the safety and efficacy of the study drug, SCH 417690 (an orally administered HIV-1 entry inhibitor), in HIV-infected, treatment-experienced subjects. SCH 417690 acts by specifically blocking the CCR5 co-receptor. The purpose of the study is to determine what dose is most effective and to determine what side effects are reported. Subjects will be randomized to one of four treatment arms with three phases: 42-day screening, 14-day add-on phase and 46-week continuation phase. In this multi-center study, 120 subjects will be enrolled nationally with 10 subjects enrolled locally.