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

点击翻译按钮获取中文摘要

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.