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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项成人ACTG的多中心试验，由NIAID赞助，并有药物支持。该提案解决了艾滋病毒-1感染患者的优化治疗问题。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，还检查各种代谢参数，这些参数在接受艾滋病毒-1治疗的患者中经常受到干扰，通常是治疗的结果。这是一项III期开放标签随机试验，对三个抗病毒治疗组之间的病毒学失败时间进行成对比较。治疗组包括不同的蛋白酶抑制剂、核苷逆转录酶抑制剂和非核苷逆转录酶抑制剂的组合。个人将被跟踪2-3年。如果治疗无效或导致不想要的副作用，患者可能会被切换到另一种方案。次要目标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、躯干脂肪堆积、高胆固醇血症等。本文还提出了两个子研究。在第一项研究中，治疗前、治疗后4周和24周的臂动脉反应性将通过对血管活性刺激的反应来评估。第二个子研究将检查病毒动力学，以病毒衰减率衡量。这项研究继续招募受试者。目前还没有初步发现的报道。

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.