PATIENT RECRUITMENT & CLINICAL MANAGEMENT CORE

描述（改编自申请人摘要） 该提案将建立一个临床核心，以招募和留住艾滋病毒感染者- 受感染的受试者，用于随附文件中提出的研究 Samuel Klein和Kevin Yarasheski博士的申请。 合适的HIV 将确定受试者以及目前正在接受治疗的受试者， 招募的 这将包括以前没有接受过抗逆转录病毒治疗的患者， 以及那些接受有效治疗的人--有或没有蛋白酶 抑制剂的 将定义显著代谢综合征， 在这些检查中， 高脂血症和中心性肥胖。 有和没有这个的病人 将招募综合征患者。 最重要的是，将是科目谁是 目前正在接受基于蛋白酶抑制剂的治疗， 代谢或其他副作用，谁会选择转换为 替代疗法。 临床中心的研究人员将确保 这种开关在医学上是合适的， 在可能的情况下使用替代的有效抗逆转录病毒疗法。调查人员 将在密集的 调查，并在相关的抗逆转录病毒疗法的变化。 该提案预计可以招募大约20名新患者 在这项临床研究中，每年，总入组目标为100 科目 研究将在大学的普通临床 研究中心和艾滋病临床试验单位的诊所。 我们将 将试验中的注册人数与圣路易斯的流行病人口统计相匹配。 我们 因此，预计至少35%的入学人数将来自非洲- 美国社区，至少10%将是妇女。

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.