A RANDOMIZED STUDY OF TREATMENT WITH TENOFOVIR DF, EMTRICITABINE, AND LOPINAVIR

替诺福韦 DF、恩曲他滨和洛匹那韦治疗的随机研究

• 批准号: 7717545
• 负责人: MITCHELL J GOLDMAN
• 金额: $ 0.89万
• 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/7717545
• 关键词: Acute; Adherence; Blood; Clinical; Computer Retrieval of Information on Scientific Projects Database; Counseling; Evaluation; Funding; Grant; HIV-1; Immunologics; Infection; Institution; Label; Lopinavir; Lopinavir/Ritonavir; Protocols documentation; Randomized; Research; Research Personnel; Resources; Source; Tenofovir; Testing; United States National Institutes of Health; Urine; Week; antiretroviral therapy; emtricitabine

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 is a two-step, 96-week randomized, open-label study of the effects on the virologic setpoint of 36 weeks of potent antiretroviral therapy administered during early but not acute HIV-1 infection. One hundred fifty recently HIV-1 infected subjects will be randomized to Step 1 in a 1:1 fashion to receive 36 weeks of tenofovir DF, emtricitabine, and lopinavir/ritonavir versus no treatment. Any subject not on treatment who meets clinical, virologic or immunologic criteria for treatment initiation as per protocol specifications will be counseled and offered treatment and entry into Step 2 of the study. Step 2 is the re-initiation of antiretroviral therapy in subjects randomized to treatment who have completed the 36-week course of treatment or have discontinued treatment prematurely and now meet study criteria for treatment re-initiation; or initiation of antiretroviral therapy in subjects randomized to no treatment at entry who now meet study criteria for treatment initiation. Subjects will undergo physical exams, blood and urine testing, and adherence evaluations.

这个子项目是许多利用 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来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项为期96周的两步、随机、开放标签研究，旨在评估在早期但非急性HIV-1感染期间给予36周强效抗逆转录病毒治疗对病毒学设定点的影响。 将150例近期感染HIV-1的受试者以1：1的比例随机分配至第1步，接受36周替诺福韦DF、恩曲他滨和洛匹那韦/利托那韦治疗，与不接受治疗相比。 任何未接受治疗的受试者，如果符合方案规定的临床、病毒学或免疫学治疗开始标准，将接受咨询并提供治疗，然后进入研究的第2步。 第2步是在已完成36周疗程或已提前中止治疗且目前符合研究重新开始治疗标准的随机分配至治疗组的受试者中重新开始抗逆转录病毒治疗;或在入组时随机分配至未接受治疗且目前符合研究开始治疗标准的受试者中开始抗逆转录病毒治疗。 受试者将接受体格检查、血液和尿液检查以及依从性评价。