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: 7379528
• 负责人: Paul R Skolnik
• 金额: $ 0.11万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379528
• 关键词: HIV; INFECTED; SUBJECTS; COMPARING; TENOFOVIR

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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。本研究的目的是比较替诺福韦DF和恩曲他滨的简化剂量方案与康比韦加依法韦仑治疗HIV-1感染的抗逆转录病毒初治者的疗效。已经证明，康比韦和埃法维伦兹是一种特别有效的初始方案。因此，这项研究将对替诺福韦DF、恩曲他滨和依法韦仑与康比韦和依法韦仑进行比较。这项研究还将比较替诺福韦DF和恩曲他滨与Efavirenz联合使用与Combivir和Efavirenz联合使用的安全性。将使用全身DXA进行形态评估，以试图确定NRTI在脂肪营养不良的发展中的作用。主要目的：评估替诺福韦DF和恩曲他滨联合依法韦仑治疗HIV-1感染的ART受试者相对于康比韦和Efavirenz的非劣势。