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

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 II 期、随机、双盲、多中心研究，涉及三种剂量的 SCH 417690 与匹配的安慰剂，分三个阶段：(1) 42 天筛选阶段； (2) 14天双盲、随机、安慰剂对照、附加阶段，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 是一种实验药物（未经美国食品和药物管理局批准）。它是一类名为 CCR5 受体阻滞剂的新型药物的成员，可阻止 HIV 进入 T 细胞（抵抗感染的血细胞）的一种方式。要进入 T 细胞，HIV 需要同时抓住细胞的两个部分（如门）。一扇“门”称为 CD4。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。大多数艾滋病毒感染者都患有 R5 型艾滋病毒。 SCH 417690 是用来阻挡 CCR5“门”的。 SCH 417690 无法阻止 X4 HIV 进入 T 细胞。 受试者需要服用 FDA 批准的其他抗 HIV 药物，包括利托那韦（Norvir¿，RTV）。 RTV 属于一组称为蛋白酶抑制剂的药物。该研究不会提供 RTV 和其他抗 HIV 药物。 这是一项为期 48 周的研究（无论步骤如何），受试者为 120 名年龄 > 18 岁的 HIV 感染男性和女性，CD4 细胞计数 > 50 个细胞/mm3，HIV-1 RNA > 5000 拷贝/mL，采用当前含利托那韦（100-800 毫克/天）的抗逆转录病毒治疗方案，在筛选 HIV-1 RNA 分离株时检测到仅 R5 表型，当前治疗方案在研究开始前 8 周内保持稳定，并且至少一种其他 3 种或更多抗逆转录病毒药物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.