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: 7605983
• 负责人: Henry H. BALFOUR
• 金额: $ 0.33万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605983
• 关键词: AIDS clinical trial group; Abdomen; Acquired Immunodeficiency Syndrome; Adult; Anti-HIV Agents; Back; Blood Glucose; Cholesterol; Class; Communicable Diseases; Computer Retrieval of Information on Scientific Projects Database; DEXA; Effectiveness; Fatty acid glycerol esters; Funding; Grant; HIV; HIV Infections; Hemorrhage; Institutes; Institution; Label; Leg; Lopinavir; Metabolism; Other Body Part; Pharmaceutical Preparations; Phase; Protease Inhibitor; Randomized; Research; Research Personnel; Resources; Safety; Scanning; Source; Time; Treatment Protocols; Triglycerides; United States National Institutes of Health; Upper arm; Week; nucleoside analog

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.

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。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项成人艾滋病临床试验组的多中心试验，由美国国立卫生研究院、美国国立过敏和传染病研究所艾滋病分部赞助。 这项研究将比较三种不同的抗艾滋病毒药物方案作为艾滋病毒感染的首次治疗。 目前抗HIV药物主要有1 ~ 3类：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种都使用了两种抗HIV药物类别的药物，但保留了第三类药物。 每种治疗方案都保留了不同种类的抗艾滋病毒药物。 这项研究将着眼于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种抗艾滋病毒药物对受试者代谢变化的影响，因为接受艾滋病毒治疗的人有时会出现高血糖，血液中脂肪（如甘油三酯和胆固醇）水平高于正常水平，手臂和腿部脂肪减少，或身体其他部位（如上背部和腹部）脂肪增加。 将要求GCRC对同意参加本试验的受试者进行DEXA扫描。 受试者将在研究入组、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转换抗HIV方案或提前终止研究，则将接受DEXA扫描。