PATIENT RECRUITMENT & CLINICAL MANAGEMENT CORE

描述(改编自申请人的摘要) 这项提议将建立一个临床核心，以招募和保留艾滋病毒- 随附的调查建议的感染对象 塞缪尔·克莱因博士和凯文·雅拉什斯基博士的申请。适合的HIV病毒 将确定受试者以及目前正在接受治疗的人，并 被招募了。这将包括之前没有接受抗逆转录病毒治疗的患者， 以及那些接受有效治疗的患者-使用或不使用蛋白酶 抑制剂。为此目的，将定义显著的代谢综合征 在这些研究中，作为糖耐量异常的患者， 高甘油三酯血症和中心性肥胖。有无此病的患者 综合症将被招募。最重要的是，将是那些 目前正在接受基于蛋白酶抑制剂的治疗，他们经历了 新陈代谢或其他副作用，以及谁会选择改用 不同的养生法。临床中心的研究人员将确保 这样的开关在医学上是合适的，可以维持病毒抑制 在可能的情况下使用其他有效的抗逆转录病毒方案。调查人员 来自临床的核心将监测患者在强化治疗期间 在抗逆转录病毒治疗的变化期间进行调查，并在相关情况下进行调查。 该提案预计可以招收大约20名新患者。 在这项临床研究中，每年总招生目标为100人 研究对象。研究将在大学的普通临床进行 在艾滋病研究中心和艾滋病临床试验股的诊所。我们会 试验的登记人数与圣路易斯疫情的人口学特征相匹配。我们 因此，预计至少35%的入学人数将来自非洲人- 美国社区，至少10%将是女性。

DESCRIPTION (Adapted from the applicant's abstract) This proposal will establish a clinical core to recruit and retain HIV- infected subjects for the investigations proposed in the accompanying applications from Drs. Samuel Klein and Kevin Yarasheski. Suitable HIV subjects as well as those currently receiving treatment will be identified and recruited. This will include patients without prior antiretroviral therapy, as well as those receiving potent treatment - with or without protease inhibitors. Significant metabolic syndrome will be defined, for the purposes of these investigations as patients with an abnormal glucose intolerance, hypertriglyceridemia, and central adiposity. Patients with and without this syndrome will be recruited. Of paramount importance, will be subjects who are currently receiving protease-inhibitor based treatments who experience metabolic or other side-effects and who will choose to be switched to alternative regimens. The investigators from the clinical core will ensure that such switches are medically appropriate, maintaining viral suppression where possible using alternative potent antiretroviral regimens. Investigators from the clinical core will monitor patients both during the intensive investigations, and where relevant, during changes in antiretroviral therapy. The proposal projects that approximately twenty new patients can be enrolled in this clinical research each year, with a total enrollment target of 100 subjects. Research will be conducted in the University's General Clinical research center and at the clinics of the AIDS Clinical Trials Unit. We will match enrollment in trials to the demography of the epidemic in St. Louis. We therefore anticipate that at least 35% of enrollment will be from the African- American community and at least 10% will be women.