ACTG A5142: COMPARISON OF THREE ANTIVIRAL REGIMENS FOR INITIAL THERAPY OF HIV-1

ACTG A5142：HIV-1 初始治疗的三种抗病毒治疗方案的比较

• 批准号: 7605709
• 负责人: JUDITH Ann ABERG
• 金额: $ 0.44万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605709
• 关键词: AIDS clinical trial group; Address; Adult; Adverse effects; Antiviral Agents; Combined Modality Therapy; Computer Retrieval of Information on Scientific Projects Database; Enrollment; Failure; Fatty acid glycerol esters; Funding; Grant; HIV-1; Individual; Infection; Institution; Label; Lipoatrophy; Measures; Metabolic; Multicenter Trials; National Institute of Allergy and Infectious Disease; Nucleosides; Patients; Peripheral; Pharmacologic Substance; Phase; Protease Inhibitor; Randomized Controlled Clinical Trials; Rate; Reporting; Research; Research Personnel; Resources; Reverse Transcriptase Inhibitors; Source; Stimulus; Testing; Time; Treatment Protocols; United States National Institutes of Health; Viral; Viral Load result; Week; brachial artery; hypercholesterolemia; non-nucleoside reverse transcriptase inhibitors; response; trial comparing

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 multicenter trial of the adult ACTG that is sponsored by NIAID and with pharmaceutical support. The proposal addresses the problem of optimization of treatment for patients with HIV-1 infection. The investigators will test various combinations of therapy and examine not only the effects on viral load but also a variety of metabolic parameters that are frequently perturbed in HIV-1-treated patients, often as a result of therapy. This is a phase III, open-label randomized trial that compares the time to virologic failure pairwise between three antiviral treatment groups. The treatment groups include varying combinations of protease inhibitors, nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors. Individuals will be followed between 2-3 years. If therapy becomes ineffective or leads to unwanted side effects, the patient may be switched to another regimen. Secondary objectives include an analysis of peripheral lipoatrophy, as well as various metabolic abnormalities, such as hyperlactatemia, truncal fat accumulation, hypercholesterolemia, etc. in the various treatment groups. Two substudies are also proposed. In the first, brachial artery reactivity prior to and 4 and 24 weeks after therapy will be assessed by response to vasoactive stimuli. The second substudy will examine viral dynamics as measured by viral decay rates. The study continues to enroll subjects. No preliminary findings have been reported yet.

这个子项目是许多利用 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ACTG的多中心试验，由NIAID申办并获得药物支持。 该提案涉及艾滋病毒1型感染患者的最佳治疗问题。 研究人员将测试各种治疗组合，不仅检查对病毒载量的影响，还检查HIV-1治疗患者中经常受到干扰的各种代谢参数，这些参数通常是治疗的结果。 这是一项III期、开放标签随机试验，比较了三个抗病毒治疗组之间的病毒学失败时间。 治疗组包括蛋白酶抑制剂、核苷逆转录酶抑制剂和非核苷逆转录酶抑制剂的不同组合。 个人将被跟踪2-3年。 如果治疗变得无效或导致不必要的副作用，患者可能会切换到另一个方案。 次要目的包括分析不同治疗组的外周脂肪萎缩以及各种代谢异常，如高乳酸血症、躯干脂肪蓄积、高胆固醇血症等。 还提出了两个子研究。 首先，将通过对血管活性刺激的反应评估治疗前和治疗后4周和24周的肱动脉反应性。 第二子研究将通过病毒衰变率来检查病毒动态。 研究继续招募受试者。 目前尚未报告初步调查结果。