A5202

A5202

• 批准号: 7959671
• 负责人: CARMEN D ZORRILLA
• 金额: $ 7.19万
• 依托单位: UNIVERSITY OF PUERTO RICO MED SCIENCES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7959671
• 关键词: Age-Years; Anti-Retroviral Agents; Atazanavir; Blinded; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Development; Enrollment; Failure; Funding; Grant; HIV-1; Infection; Institution; Laboratories; Lamivudine; Medical; Pharmaceutical Preparations; Phase; Placebos; Plasma; Population; RNA; Randomized; Research; Research Personnel; Resources; Ritonavir; Safety; Sample Size; Science; Signs and Symptoms; Source; Tenofovir; Time; Treatment Protocols; United States National Institutes of Health; Upper arm; Woman; abacavir; comparative efficacy; design; efavirenz; emtricitabine; men; open label; research and development

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

该副本是使用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这是调查员的机构。 设计A5202是一项IIIB期，随机，四臂研究，将开放标签的利托纳维尔（RTV）增强的Atazanavir（ATV）与Efavirenz（EFV）进行比较，与每天的Emtricatabine（FTC）/Tenofovir（FTC）/lamciv（tddfir）（tddfir）（tddfir）（EFV）（EFV）（EFV）（EFV）与FTC/TDF与RTV增强的ATV或EFV作为HIV-1感染的初始疗法相比，与FTC/TDF相比，ABC/3TC部分盲目的ABC/3TC。 持续时间：大约96周的最后一个主题入学。 样本量：A5202将招募1800名受试者（每个治疗臂450）。 人口：HIV-1感染，抗逆转录病毒（ARV）药物no ve男性和女性E16岁，具有血浆HIV-1 RNA水平1000份/ml，在研究入学前90天内获得。 入境对象的方案将被随机分为以下一个： 臂A：EFV 600 mg QD + FTC 200 mg/tdf 300 mg QD + ABC/3TC安慰剂QD 手臂B：EFV 600 mg QD + ABC 600 mg/3tc 300 mg QD + FTC/TDF安慰剂QD ARM C：ATV 300 mg QD，带RTV 100 mg QD + FTC 200 mg/tdf 300 mg QD + ABC/3TC安慰剂QD 手臂D：ATV 300 mg QD，带RTV 100 mg QD + ABC 600 mg/3tc 300 mg QD + FTC/TDF安慰剂QD 这三个主要目标是： 1。要比较病毒学衰竭方案之间的病毒学效率定义为确认在16周或24周之前和24周之前或之前在24周或之后24周或E200拷贝/mL确认血浆HIV-1 RNA水平E1000拷贝/ml。 2。要将安全性与安全性的安全性与第3级或4级征兆，症状或实验室异常的首次发展的时间进行比较，至少比基线时高一个级。 3。要比较方案之间的耐受性，可耐受性定义为在初始治疗方案中改变一种或多种药物的时间