ACTG A5206: IMPACT ON DYSLIPIDEMIA OF ADDING TENOFOVIR TO ARV THERAPY IN HIV

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。 这项安慰剂对照的交叉研究将检验在非高密度脂蛋白胆固醇和甘油三酯升高的患者中，在稳定的抗逆转录病毒疗法中加入富马酸替诺福韦(TDF)与安慰剂的疗效。TDF是替诺福韦的核苷酸类似物和前药，具有内在的降血脂作用。以前的研究中，TDF取代了其他核苷，导致了血脂的降低。这不允许区分TDF的效果和去除其他药物的效果。这项研究将通过将TDF添加到稳定的方案中来绕过这个问题。交叉研究的使用将消除其他变量(例如，饮食、锻炼)的影响，这可能会混淆解释。研究设计将有助于明确TDF的实际作用。接受TDF或安慰剂的患者将接受为期12周的TDF或安慰剂治疗，进行为期4周的洗涤，然后交叉接受替代治疗。主要终点是在基线、12周、16周和28周空腹非高密度脂蛋白胆固醇。次级终点将评估TDF的抗病毒效果以及TDF潜在肾毒性的标志物。发现TDF的内在降血脂作用可能会改变一线治疗的建议，用于治疗已有高脂血症和心脏病危险因素的个体。这项研究与艾滋病有关。

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 placebo-controlled crossover study will examine the efficacy of adding tenofovir disoproxil fumarate (TDF) versus placebo to a stable antiretroviral regimen in individuals who have elevated non-HDL cholesterol and triglycerides. TDF is a nucleotide analogue and prodrug of tenofovir and has intrinsic antilipidemic effects. Previous studies wherein TDF replaced other nucleosides resulted in decreased lipid values. This did not allow for differentiating the effects of TDF vs the effects of removing other drugs. This study will circumvent this problem by adding TDF to a stable regimen. The use of a crossover study will eliminate the effects of other variables (e.g., diet, exercise), which may confound the interpretation. The study design will help clear up the actual role of TDF. Patients in a given arm will receive TDF or placebo for 12 weeks, have a 4-week washout, and cross over to the alternate treatment. The primary endpoint is fasting non-HDL cholesterol at baseline, weeks 12, 16, and 28. Secondary endpoints will evaluate the antiviral effect of TDF as well as markers of the potential renal toxicity of TDF. Finding intrinsic antilipidemic effects of TDF may alter recommendations for first-line therapy when dealing with an individual that has pre-existing risk factors for hyperlipidemia and heart disease. This study is AIDS-related.