ACTG A5142: A PHASE III, RANDOMIZED, OPEN-LABEL COMPARISON OF LOPINAVIR/RITONAVI

ACTG A5142：洛匹那韦/利托那韦的 III 期、随机、开放标签比较

• 批准号: 7375900
• 负责人: JENNIFER BALFOUR
• 金额: $ 1.57万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375900
• 关键词: ACTG; A5142; PHASE; III; RANDOMIZED

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 is a multi-center trial of the Adult AIDS Clinical Trial Group sponsored by the National Institutes of Health, National Institute of Alergy and Infectious Diseases, Division of AIDS. This study will compare three different anti-HIV drug regimens as first-time treatments for HIV infection. Currently anti-HIV drugs are from one to three classes: non-nucleoside analogues, nucleoside analogues and protease inhibitors. Each of the three regimens in this study use medication from two anti-HIV drug classes but spares a third class. Each regimen spares a different class of anti-HIV drug. This study will look at the effectiveness and safety of the three drug regimens and how well these regimens are tolerated. The study will also look at the effect of these three anti-HIV regiments on changes in the changes in the subjects' metabolism because people treated for HIV sometimes develop high blood sugar, higher than normal levels of fats (such as triglycerides and cholesterol) in their blood, loss of fat in the arms and legs, or increased fat in other parts of the body such as the upper back and abdomen. The GCRC will be asked to perform DEXA scans on the subjects who agree to participate in this trial. Subjects will recieve DEXA scans at study entry, week 48 and week 96. Subjects will receive DEXA scans if they need to switch anti-HIV regimens during the course of the study or if they discontinue the study prematurely.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这是由美国国立卫生研究院，美国国家卫生研究院和艾滋病部门赞助的成人艾滋病临床试验小组的多中心试验。这项研究将比较三种不同的抗HIV药物方案作为HIV感染的首次治疗。目前，抗HIV药物从一到三个类别：非核苷类似物，核苷类似物和蛋白酶抑制剂。这项研究中的三种方案中的每一个都使用两种抗HIV药物类别的药物，但避免了第三类。每种方案都助长了不同类别的抗HIV药物。这项研究将研究三种药物方案的有效性和安全性以及这些方案的耐受性。该研究还将研究这三个抗HIV制定方案对受试者代谢变化的变化的影响，因为接受HIV治疗的人有时会出现高血糖，高于正常水平的脂肪（例如甘油三酸酯和胆固醇）在血液中的脂肪，手臂和腿部脂肪的损失，或者在其他部位的脂肪损失，或者在其他部位增加了脂肪。将要求GCRC对同意参加此试验的受试者进行DEXA扫描。受试者将在第48周和第96周学习DEXA扫描。如果受试者在研究过程中需要切换反HIV方案，或者他们过早地停止研究，则将获得DEXA扫描。