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

确定添加替诺福夫对血脂异常影响的试点研究

• 批准号: 7717546
• 负责人: SAMIR KUMAR GUPTA
• 金额: $ 0.32万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717546
• 关键词: Computer Retrieval of Information on Scientific Projects Database; Double-Blind Method; Dyslipidemias; Fasting; Funding; Goals; Grant; High Density Lipoprotein Cholesterol; Highly Active Antiretroviral Therapy; Institution; Laboratories; Lipids; Pilot Projects; Placebo Control; Placebos; Randomized; Research; Research Personnel; Resources; Source; Tenofovir; Testing; Treatment Protocols; Triglycerides; United States National Institutes of Health; Viral Load result; Visit; Week; day; treatment duration

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 A5206是一项双盲，随机，安慰剂对照的跨界试验研究，可确定在稳定的高度活性抗逆转录病毒疗法（HAART）对HIV感染受试者中稳定的高度活性抗逆转录病毒疗法（HAART）方案中添加替诺福韦（TDF）对降低脂质降低作用的疗效。 该研究的目的是评估是否有对TDF有好处的证据，然后将其用于证明一项更大的研究是合理的。 该研究将包括56名患有血脂异常的受试者（甘油三酸酯200 mg/dl和非HDL胆固醇160 mg/dl），在研究入学前90天，在稳定的HAART上受到病毒式抑制（病毒载荷400拷贝/ml），他们在研究入学前90天，他们不打算改变HAART的研究，以改变他们的HAART治疗32周的研究。 受试者将接受治疗（TDF或安慰剂在TDF之间随机分组）12周，然后进行4周的冲洗期，然后在另一种治疗中进行12周（分别用于TDF或TDF的安慰剂）。 在每个治疗期开始之前，将在每个治疗期内每4周之前每4周都有禁食脂质面板。 受试者将进行14次学习访问，进行体格检查和其他实验室检查。