THE EFFECTS OF LOW-DOSE RITONAVIR ON THE RENAL CLEARANCE OF TENOFOVIR

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。最近有报道称，患有人类免疫缺陷病毒（HIV）的患者在服用药物Viread¿时出现肾脏毒性。这些患者中的许多人还服用低剂量（100毫克，每日1次或2次）利托那韦作为其艾滋病毒治疗方案的一部分。这项研究旨在测试在服用Viread¿的HIV患者中观察到的毒性是否可能是由Viread¿和利托那韦在肾脏中的药物相互作用引起的。本研究的目的是测试服用含有低剂量利托那韦（如Kaletra）的HIV治疗方案的患者与服用不含蛋白酶抑制剂的HIV治疗方案的患者相比，肾脏排泄到尿液中的病毒量是否存在差异。这项研究将需要两次研究访问：一次筛查访问（大约1小时）和一次24小时的夜间访问。研究参与者将在研究中使用他们自己的HIV药物。在两次访问中，将收集血液和尿液样本，以检测这些液体中的病毒浓度。我们将比较两组患者尿液和血液中Viread¿的水平。我们还将抽血检查DNA，或遗传基因物质。这些DNA将被用来确定人体吸收、代谢、运输、消除和对HIV药物反应的遗传能力。

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. There have recently been reports of patients with human immunodeficiency virus (HIV) developing kidney toxicities while taking the drug Viread¿. Many of these patients were also taking low-dose (100 mg once or twice daily) ritonavir as part of their HIV treatment regimen. This study is designed to test if the toxicities observed in HIV patients taking Viread¿ might be caused by a drug interaction in the kidney between Viread¿ and ritonavir. The purpose of this study is to test whether there are differences in the amount of Viread¿ the kidneys excrete into the urine in patients who are taking a HIV regimen containing low-dose ritonavir (as Kaletra¿) compared to patients who are taking a HIV regimen that does not contain a protease inhibitor. This study will require 2 study visits: one screening visit (approximately 1 hour in length) and one 24-hour overnight visit. Study participants will use their own supply of HIV medications for the study. Blood and urine samples will be collected at both visits to look for the levels of Viread¿ in these fluids. We will compare the levels of Viread¿ in the urine and blood between the 2 groups of patients. We will also draw blood to look at DNA, or inherited genetic material. The DNA will be used to determine the body's inherited ability to absorb, metabolize, transport, eliminate, and respond to HIV medications.