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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 第二阶段，随机、双盲、多中心研究，分三个阶段进行：(1)42天的筛选阶段；(2)14天的双盲、随机、安慰剂对照的添加阶段，以评估SCH 417690的抗逆转录病毒活性；(3)46周持续阶段，以评估SCH 417690的长期安全性和耐受性。SCH 417690是一种实验性药物(未经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的成员，这种药物可以阻断HIV进入T细胞(对抗感染的血细胞)的一条途径。要进入T细胞，HIV需要同时抓住细胞的两个部分(如门)。其中一扇“门”被称为CD_4。另一个“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。大多数艾滋病毒携带者都感染了R5艾滋病毒。SCH 417690是用来挡住CCR5“门”的。SCH 417690不能阻止X4艾滋病毒进入T细胞。受试者将需要服用FDA批准的其他抗艾滋病毒药物，包括利托那韦(Norvir？，RTV)。RTV属于一种名为蛋白酶抑制剂的药物。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(无论步骤如何)，120名艾滋病毒感染男性和女性&>18岁，在当前含有利托那韦(100-800毫克/天)的抗逆转录病毒疗法中，CD4细胞计数为50个/mm3，HIV-1RNA&gt；5000拷贝/毫升，在筛选HIV-1RNA分离物中检测到仅R5的表型，目前的疗法在进入研究之前的8周内稳定，并且至少其他3种或更多药物抗逆转录病毒疗法的病毒学失败。

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.