A5202

A5202

基本信息

项目摘要

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. DESIGN A5202 is a phase IIIB, randomized, four-arm study, comparing 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 of partially blinded ABC/3TC compared to FTC/TDF in combination with either RTV-enhanced ATV or EFV as initial therapy for HIV-1 infection. DURATION: Approximately 96 weeks beyond the enrollment of the last subject. SAMPLE SIZE: A5202 will enroll 1800 subjects (450 per treatment arm). POPULATION: HIV-1-infected, antiretroviral (ARV) drug-na¿ve men and women e16 years of age with plasma HIV-1 RNA levels 1000 copies/mL obtained within 90 days prior to study entry. REGIMEN At entry subjects will be randomized to one of the following: ARM A: EFV 600 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC placebo QD ARM B: EFV 600 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF placebo QD ARM C: ATV 300 mg QD with RTV 100 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC placebo QD ARM D: ATV 300 mg QD with RTV 100 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF placebo QD The three primary objectives are: 1. To compare virologic efficacy between regimens with virologic failure defined as the time to confirmed plasma HIV-1 RNA level e1000 copies/mL at or after 16 weeks and before 24 weeks or e200 copies/mL at or after week 24. 2. To compare the safety between regimens with safety defined as the time to first development of Grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline. 3. To compare the tolerability between regimens with tolerability defined as the time to change in one or more drugs in the initial treatment regimen
这个子项目是众多研究子项目之一

项目成果

期刊论文数量(0)
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专利数量(0)

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CARMEN D ZORRILLA其他文献

CARMEN D ZORRILLA的其他文献

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{{ truncateString('CARMEN D ZORRILLA', 18)}}的其他基金

Integrated University of Puerto Rico Clinical Trials Unit
波多黎各综合大学临床试验单位
  • 批准号:
    10166084
  • 财政年份:
    2020
  • 资助金额:
    $ 7.19万
  • 项目类别:
Hurricane-related maternal stress, infant outcomes and resilience factors
与飓风相关的孕产妇压力、婴儿结局和复原力因素
  • 批准号:
    9794018
  • 财政年份:
    2018
  • 资助金额:
    $ 7.19万
  • 项目类别:
PR-CCHD: PUERTO RICO COMPREHENSIVE CENTER FOR THE STUDY OF HIV-AIDS DISPARITIES
PR-CCHD:波多黎各艾滋病毒与艾滋病差异研究综合中心
  • 批准号:
    8359931
  • 财政年份:
    2011
  • 资助金额:
    $ 7.19万
  • 项目类别:
Puerto Rico Comprehensive Center for HIV Disparities
波多黎各艾滋病毒差异综合中心
  • 批准号:
    7929859
  • 财政年份:
    2009
  • 资助金额:
    $ 7.19万
  • 项目类别:
CROSSOVER STUDY TO COMPARE TABLET PC AND PAPER SURVEYS
比较平板电脑和纸质调查的交叉研究
  • 批准号:
    7961270
  • 财政年份:
    2009
  • 资助金额:
    $ 7.19万
  • 项目类别:
FACULTY DVMT & CLIN BEHV RES CORES
教职人员 DVMT
  • 批准号:
    7961262
  • 财政年份:
    2009
  • 资助金额:
    $ 7.19万
  • 项目类别:
Puerto Rico Comprehensive Center for HIV Disparities
波多黎各艾滋病毒差异综合中心
  • 批准号:
    7899582
  • 财政年份:
    2009
  • 资助金额:
    $ 7.19万
  • 项目类别:
Puerto Rico Comprehensive Center for HIV Disparities
波多黎各艾滋病毒差异综合中心
  • 批准号:
    7920749
  • 财政年份:
    2009
  • 资助金额:
    $ 7.19万
  • 项目类别:
Mentoring Institute for HIV and Mental Health Related Research of the University
大学艾滋病毒和心理健康相关研究指导研究所
  • 批准号:
    7871076
  • 财政年份:
    2009
  • 资助金额:
    $ 7.19万
  • 项目类别:
University of Puerto Rico Mentoring Institute for HIV Mental Health Research
波多黎各大学艾滋病毒心理健康研究辅导研究所
  • 批准号:
    8467746
  • 财政年份:
    2008
  • 资助金额:
    $ 7.19万
  • 项目类别:

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RESISTANCE OF HIV-1 TO ANTI-RETROVIRAL AGENTS
HIV-1 对抗逆转录病毒药物的耐药性
  • 批准号:
    3030975
  • 财政年份:
    1993
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