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

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 A5206 是一项双盲、随机、安慰剂对照、交叉试点研究，旨在确定在稳定的高效抗逆转录病毒治疗 (HAART) 方案中添加替诺福韦 (TDF) 对患有血脂异常的 HIV 感染受试者的降脂效果。 该研究的目的是评估是否有证据表明 TDF 有益，然后将其用于证明更大规模研究的合理性。 该研究将包括 56 名患有血脂异常的受试者（甘油三酯为 200 mg/dL，非 HDL 胆固醇为 160 mg/dL），他们在研究开始前 90 天通过稳定 HAART 进行病毒学抑制（病毒载量 400 拷贝/mL），并且不打算在研究的 32 周内改变其 HAART 方案。 受试者将接受 12 周的治疗（随机选择 TDF 或 TDF 安慰剂），然后是 4 周的清除期，然后接受 12 周的其他治疗（TDF 分别为安慰剂或 TDF）。 每个治疗期开始前以及每个治疗期每 4 周将进行一次空腹血脂检查。 受试者将进行 14 次研究访问，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.