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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。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表示。列出的机构是 对于中心，这不一定是调查员的机构。 这是由NIAID赞助和药物支持赞助的成人ACTG的多中心试验。 该提案解决了HIV-1感染患者优化治疗的问题。 研究人员将测试治疗的各种组合，不仅检查对病毒负荷的影响，而且还要检查各种代谢参数，这些参数经常在HIV-1治疗的患者中受到干扰。 这是一项III期开放标签随机试验，将三个抗病毒治疗组之间的病毒学衰竭时间比较。 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。 个人将在2 - 3年之间遵循。 如果治疗无效或导致不良副作用，则可能会切换到另一种方案。 次要目标包括对各种治疗组中的多种代谢异常的分析以及各种代谢异常，例如高乳酸血症，截短脂肪积累，高胆固醇血症等。 还提出了两种取代物。 首先，将通过对血管活性刺激的反应来评估治疗前的臂动脉反应性。 第二个蛋白将检查通过病毒衰减速率测量的病毒动力学。 该研究继续注册受试者。 尚未报告初步发现。