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

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH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 中心，不一定是研究者的机构。 A5206是一项双盲、随机、安慰剂对照、交叉的初步研究，旨在确定在HIV感染伴血脂异常受试者中，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）的降脂作用的疗效。 该研究的目的是评估是否有证据表明TDF有益，然后将用于证明更大规模的研究。 该研究将纳入56名血脂异常受试者（同时患有三酸甘油酯 200 mg/dL和非HDL胆固醇 160 mg/dL），在进入研究前接受稳定HAART治疗90天病毒学抑制（病毒载量400拷贝/mL），并且在研究的32周内不计划改变其HAART方案。 受试者将接受12周的治疗（随机分配至TDF或TDF安慰剂组），随后为4周的洗脱期，随后接受12周的其他治疗（分别为TDF安慰剂组或TDF组）。 每个治疗期开始前以及整个治疗期每4周一次进行空腹血脂检查。 受试者将接受14次研究访视，并接受体格检查和额外的实验室检查。

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.