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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个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，不一定是研究者的机构。 一项比较3种剂量SCH 417690与匹配安慰剂的II期、随机化、双盲、多中心研究，分为3个阶段：（1）42天筛选期;（2）14天双盲、随机化、安慰剂对照、添加治疗期，以评估SCH 417690的抗逆转录病毒活性;（3）46？一周持续阶段，评估SCH 417690的长期安全性和耐受性。 SCH 417690是一种实验性药物（未经美国食品药品监督管理局批准）。它是一种名为CCR 5受体阻滞剂的新型药物的一员，这种药物可以阻断HIV进入T细胞（抵抗感染的血细胞）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（如门）。其中一个“门”叫做CD 4。另一个“门”是CCR 5或CXCR 4。使用CCR 5“门”的病毒被称为R5 HIV，使用CXCR 4“门”的病毒被称为X4 HIV。大多数艾滋病毒感染者携带R5艾滋病毒。SCH 417690用于堵塞CCR 5“门。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属于一组称为蛋白酶抑制剂的药物。研究将不提供RTV和其他抗HIV药物。 为期48周的研究120名HIV感染的男性和女性，年龄>18岁，CD 4+细胞计数>50个细胞/mm 3，HIV-1 RNA >5000拷贝/mL，使用目前的含利托那韦的（100-800 mg/天）抗逆转录病毒方案，在筛选HIV-1 RNA分离株时检测到仅R5表型，在进入研究之前，当前方案稳定8周，并且在至少一种其他3种或更多种药物抗逆转录病毒方案中病毒学失败。

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.