COMPARISON OF INITIAL ANTRETROVIRAL REGIMENS (HIV)

初始抗逆转录病毒治疗方案 (HIV) 的比较

• 批准号: 7603483
• 负责人: Ann Cornwall Collier
• 金额: $ 0.1万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603483
• 关键词: Atazanavir; Blinded; Computer Retrieval of Information on Scientific Projects Database; Daily; Enrollment; Funding; Grant; HIV Infections; Institution; Label; Lamivudine; Metabolic; Nucleosides; Phase; Randomized; Research; Research Personnel; Resources; Reverse Transcriptase Inhibitors; Ritonavir; Safety; Scanning; Source; Tenofovir; Treatment Protocols; United States National Institutes of Health; Upper arm; Week; abacavir; efavirenz; 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 phase IIIB, multicenter, randomized, four-arm study of initial therapy for HIV infection. It will compare the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced atazanavir (ATV) to efavirenz (EFV) (in combination with either daily emtricitabine [FTC]/tenofovir [TDF] or abacavir [ABC]/lamivudine [3TC]; and compare partially blinded FTC/TDF to ABC/3TC (in combination with either RTV-enhanced ATV or EFV). 1800 treatment-nanve subjects will be enrolled and followed for 96 weeks after the last subject enrolls; they will be evaluated in a standardized fashion for efficacy, safety, and tolerability. There are 3 optional substudies, including a metabolic substudy (A5224s) that requires use of the GCRC for dual-energy x-ray absorptiometry (DEXA) scans. The metabolic substudy will evaluate the metabolic changes in 250 subjects (20 locally) assigned to the two different nucleoside reverse transcriptase inhibitor (NRTI) combinations given in A5202.

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。 这是一项针对 HIV 感染初始治疗的 IIIB 期、多中心、随机、四组研究。 它将比较开放标签利托那韦 (RTV) 增强型阿扎那韦 (ATV) 与依非韦伦 (EFV)（与每日恩曲他滨 [FTC]/替诺福韦 [TDF] 或阿巴卡韦 [ABC]/ 联用）的疗效、安全性和耐受性拉米夫定 [3TC]；并将部分盲法 FTC/TDF 与 ABC/3TC 进行比较（与 RTV 增强型 ATV 组合） 1800 名未接受治疗的受试者将被纳入，并在最后一名受试者入组后对其进行 96 周的评估；有 3 项可选的子研究，包括代谢子研究（ A5224s），需要使用 GCRC 进行双能 X 射线吸收测定法 (DEXA) 扫描。代谢子研究将评估代谢变化。 250 名受试者（20 名本地受试者）被分配至 A5202 中给出的两种不同核苷逆转录酶抑制剂 (NRTI) 组合。