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 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。这是成人艾滋病临床试验组的一项多中心试验，由美国国立卫生研究院、国家过敏和传染病研究所艾滋病科主办。本研究将比较三种不同的抗 HIV 药物治疗方案作为 HIV 感染的首次治疗。目前抗HIV药物主要有一到三类：非核苷类似物、核苷类似物和蛋白酶抑制剂。本研究中的三种治疗方案均使用两种抗艾滋病毒药物类别的药物，但不使用第三类药物。每种治疗方案都会使用不同类别的抗艾滋病毒药物。这项研究将着眼于三种药物治疗方案的有效性和安全性以及这些治疗方案的耐受性。该研究还将研究这三种抗艾滋病毒治疗方案对受试者新陈代谢变化的影响，因为接受艾滋病毒治疗的人有时会出现高血糖、高于正常水平的脂肪（如甘油三酯和胆固醇）。他们的血液，手臂和腿部的脂肪减少，或身体其他部位（例如上背部和腹部）的脂肪增加。 GCRC 将被要求对同意参加本试验的受试者进行 DEXA 扫描。受试者将在研究开始时、第 48 周和第 96 周接受 DEXA 扫描。如果受试者在研究过程中需要更换抗 HIV 治疗方案或提前终止研究，则受试者将接受 DEXA 扫描。