A PILOT STUDY TO DETERMINE THE IMPACT ON DYSLIPIDEMIA OF THE ADDITION OF TENOFOV

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。 A5206是一项双盲、随机、安慰剂对照的交叉试验研究，旨在确定在稳定的高效抗逆转录病毒疗法(HAART)的基础上加入替诺福韦(TDF)对患有血脂异常的HIV感染患者的降脂效果。这项研究的目的是评估是否有证据表明TDF有益，这将被用来证明进行更大规模的研究是合理的。这项研究将包括56名患有血脂异常(甘油三酯200 mg/dL和非高密度脂蛋白胆固醇160 mg/dL)的受试者，他们在进入研究前90天接受稳定的HAART的病毒学抑制(病毒载量400拷贝/毫升)，并在研究的32周内不计划改变他们的HAART方案。受试者将接受为期12周的治疗(在TDF或TDF的安慰剂之间随机进行)，随后是4周的冲洗期，然后是另一种治疗(分别为TDF或TDF的安慰剂)12周。在每个治疗周期开始之前，将有空腹血脂小组，在每个治疗周期中每隔4周。受试者将进行14次考察访问，并接受体检和额外的实验室测试。

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. A5206 is a double-blind, randomized, placebo-controlled, crossover pilot study to determine the efficacy in respect to lipid-lowering effects of the addition of tenofovir (TDF) to a stable highly active antiretroviral therapy (HAART) regimen in HIV-infected subjects with dyslipidemia. The goal of the study is to assess whether there is evidence of a benefit for TDF, which would then be used to justify a larger study. The study will include 56 subjects with dyslipidemia (having both triglycerides 200 mg/dL and non HDL cholesterol 160 mg/dL), who are virologically suppressed (viral load 400 copies/mL) on stable HAART for 90 days prior to study entry, and who do not plan to change their HAART regimen for the 32 weeks of the study. Subjects will be on treatment (randomized between TDF or placebo for TDF) for 12 weeks, followed by a 4-week washout period, followed by 12 weeks on the other treatment (placebo for TDF or TDF, respectively). There will be fasting lipid panels prior to the start of each treatment period and every 4 weeks throughout each treatment period. Subjects will have 14 study visits and undergo physical exams and additional laboratory testing.