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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究旨在评估研究药物SCH 417690（一种口服HIV-1进入抑制剂）在hiv感染、有治疗经历的受试者中的安全性和有效性。SCH 417690通过特异性阻断CCR5共受体起作用。研究的目的是确定什么剂量是最有效的，并确定哪些副作用被报道。受试者将被随机分配到四个治疗组中的一个，分为三个阶段：42天的筛选期，14天的附加期和46周的延续期。在这项多中心研究中，120名受试者将在全国招募，10名受试者将在当地招募。

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.