ACTG A5211-SAFETY AND EFFICACY OF SCH 417690 IN HIV-INF, TRTMNT-EXP SUBJCTS

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。II期，随机，双盲，多中心研究，三个剂量的SCH 417690与匹配安慰剂的三个阶段：(1)42天的筛选阶段；(2)为期14天的双盲、随机、安慰剂对照、附加期，评估SCH 417690的抗逆转录病毒活性；(3) 46？持续一周，评估SCH 417690的长期安全性和耐受性。SCH 417690是一种实验性药物（未被美国食品和药物管理局批准）。它是一种名为CCR5受体阻滞剂的新型药物中的一种，这种药物可以阻断HIV进入T细胞（对抗感染的血细胞）的途径之一。为了进入T细胞，HIV需要同时抓住细胞的两个部分（就像门一样）。一扇“门”叫做CD4。另一扇“门”是CCR5或CXCR4。使用CCR5“门”的病毒称为R5 HIV，使用CXCR4“门”的病毒称为X4 HIV。大多数艾滋病毒感染者都是R5型艾滋病毒。SCH 417690是用来阻挡CCR5“门”的。SCH 417690不能阻止X4 HIV进入T细胞。受试者将需要服用其他fda批准的抗hiv药物，包括利托那韦（Norvir-， RTV）。RTV属于蛋白酶抑制剂一类药物。RTV和其他抗艾滋病毒药物将不会由该研究提供。这是一项为期48周的研究（无论步骤），研究对象为120名18岁的hiv感染者，CD4+细胞计数>50个细胞/mm3， HIV-1 RNA >5000拷贝/mL，使用当前含利托那韦（100-800 mg/天）的抗逆转录病毒治疗方案，在筛选HIV-1 RNA分离物时检测到R5-only表型，在研究开始前的8周内当前治疗方案稳定，并且至少有一种其他3种或更多药物抗逆转录病毒治疗方案的病毒学失败。

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. Phase II, randomized, double-blind, multicenter study 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. SCH 417690 is an experimental drug (not approved by the U.S. Food and Drug Administration). It is a member of a new class of drugs, called CCR5 receptor blockers, that block one of the ways HIV enters T cells (the blood cells that fight infection). To enter a T cell, HIV needs to grab onto two parts of the cell (like doors) at the same time. One "door" is called CD4. The other "door" is either CCR5 or CXCR4. Viruses that use the CCR5 "door" are called R5 HIV, and viruses that use the CXCR4 "door" are called X4 HIV. Most people with HIV have R5 HIV. SCH 417690 is made to block the CCR5 "door." SCH 417690 cannot stop X4 HIV from entering the T cell. Subjects will need to be taking other FDA-approved anti-HIV drugs, including ritonavir (Norvir-, RTV). RTV belongs to a group of drugs called protease inhibitors. RTV and the other anti-HIV drugs will not be supplied by the study. It is a 48 week study (regardless of step) of 120 HIV-infected men and women >18 years old with CD4+ cell count >50 cells/mm3, HIV-1 RNA >5000 copies/mL on a current ritonavir-containing (100-800 mg/day) antiretroviral regimen with R5-only phenotype detected on screening HIV-1 RNA isolate, current regimen stable for the 8 weeks prior to study entry and virologic failure on at least one other 3 or more drug antiretroviral regimen.