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COMPARISON OF INITIAL ANTRETROVIRAL REGIMENS (HIV)

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:
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-04-01 至 2007-09-16

项目摘要

项目成果

Ann Cornwall Collier的其他基金

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中文摘要
翻译
这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金, 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项IIIB期、多中心、随机、四臂的艾滋病毒感染初始治疗研究。它将比较开放标签利托那韦(RTV)增强型阿扎那韦(ATV)与依法韦仑(EFV)(联合每日服用恩曲他滨[FTC]/替诺福韦[TDF]或阿巴卡韦[ABC]/拉米夫定[3TC])的有效性、安全性和耐受性;并将部分失明的FTC/TDF与ABC/3TC(与RTV增强型ATV或EFV组合)进行比较。1800名治疗-NAVE受试者将在最后一名受试者登记后进行96周的跟踪调查;他们将以标准化的方式接受有效性、安全性和耐受性评估。有3个可选的子研究,包括一个代谢子研究(A5224s),它需要使用GCRC进行双能X射线吸收(DEXA)扫描。代谢子研究将评估250名受试者(当地20名)的代谢变化,这些受试者被分配到A5202中给出的两种不同的核苷逆转录酶抑制剂(NRTI)组合。
英文摘要
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.
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Clinical Core
  • 批准号:
    7854620
  • 项目类别:
  • 资助金额:
    $34.06万
  • 财政年份:
    2010
  • 负责人:
    Ann Cornwall Collier
  • 依托单位:
Clinical Cohort
  • 批准号:
    7952794
  • 项目类别:
  • 资助金额:
    $12.5万
  • 财政年份:
    2009
  • 负责人:
    Ann Cornwall Collier
  • 依托单位:
Developmental
  • 批准号:
    7479019
  • 项目类别:
  • 资助金额:
    $106.96万
  • 财政年份:
    2008
  • 负责人:
    Ann Cornwall Collier
  • 依托单位:
LOPINAVIR PHARMACOKINETICS IN MEN AND WOMEN (HIV)
  • 批准号:
    7603478
  • 项目类别:
  • 资助金额:
    $0.1万
  • 财政年份:
    2007
  • 负责人:
    Ann Cornwall Collier
  • 依托单位:
海外基金