HIV INFECTED SUBJECTS COMPARING TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE

HIV 感染者比较富马酸替诺福韦二吡呋酯和恩曲他滨

• 批准号: 7606279
• 负责人: Paul R Skolnik
• 金额: $ 0.32万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-03 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606279
• 关键词: Achievement; Anti-Retroviral Agents; Combivir; Computer Retrieval of Information on Scientific Projects Database; DEXA; Development; Dose; Funding; Grant; HIV; Institution; Lipodystrophy; Maintenance; Purpose; RNA; Relative (related person); Research; Research Personnel; Resources; Role; Safety; Source; Tenofovir; Tenofovir disoproxil fumarate; Treatment Protocols; United States National Institutes of Health; Week; 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. The purpose of this study is to compare the simplified dosing regimens of tenofovir DF and emtricitabine versus combivir plus efavirenz in the treatment of HIV-1-infected antiretroviral naive subjects. It has been demonstrated that Combivir and Efavirenz is a particularly effective initial regimen. Therefore this study will compare tenofovir DF, emtricitabine, and efavirenz versus Combivir and Efavirenz. The study will also compare the safety profile of tenofovir DF and emtricitabine in combination with Efavirenz versus Combivir and Efavirenz. Morphological assessment using whole body DEXA will be performed in an attempt to establish the role of NRTI's in the development of lipodystrophy. Primary objective: To assess non-inferiority of tenofovir DF and emtricitabine in combination with efavirenz relative to Combivir in combination with efavirenz in the treatment of HIV-1-infected ART-naive subjects as determined by the achievement and maintenance of confirmed HIV RNA < 400 copies/mL through week 48.

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。 本研究的目的是比较替诺福韦DF和恩曲他滨与combivir加依法韦仑在治疗HIV-1感染的抗逆转录病毒初治受试者的简化给药方案。已证明Combivir和依法韦仑是特别有效的初始方案。因此，本研究将比较替诺福韦DF、恩曲他滨和依法韦仑与Combivir和依法韦仑。该研究还将比较替诺福韦DF和恩曲他滨联合依法韦仑与Combivir和依法韦仑的安全性。将使用全身DEXA进行形态学评估，试图确定NRTI在脂肪代谢障碍发展中的作用。 主要目标： 评估替诺福韦DF和恩曲他滨联合依法韦仑相对于Combivir联合依法韦仑治疗HIV-1感染的ART初治受试者的非劣效性，通过第48周确认的HIV RNA < 400拷贝/mL的实现和维持来确定。