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

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。 设计 A5202是一项IIIB期、随机、四组研究，比较了开放标签利托那韦（RTV）增强阿扎那韦（ATV）与依法韦仑（EFV）的疗效、安全性和耐受性，与每日恩曲他滨（FTC）/替诺福韦（TDF）或阿巴卡韦（ABC）/拉米夫定（3 TC）联合，以及部分盲法ABC/3 TC与FTC/TDF联合RTV-增强的ATV或EFV作为HIV-1感染的初始治疗。 持续时间：最后一例受试者入组后约96周。 样本量：A5202将招募1800名受试者（每个治疗组450名）。 人口数量：HIV-1感染、抗逆转录病毒（ARV）药物初治的男性和女性，年龄≥ 16岁，在入组研究前90天内获得的血浆HIV-1 RNA水平> 1000拷贝/mL。 方案 入组时，受试者将被随机分配至以下任一组： A组： EFV 600 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3 TC安慰剂QD 臂B： EFV 600 mg QD + ABC 600 mg/3 TC 300 mg QD + FTC/TDF安慰剂QD C组： ATV 300 mg QD联合RTV 100 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3 TC安慰剂QD D组： ATV 300 mg QD + RTV 100 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF安慰剂QD 三个主要目标是： 1.比较病毒学失败方案之间的病毒学疗效，病毒学失败定义为至确认血浆HIV-1 RNA水平在16周或之后和24周之前达到e1000拷贝/mL或在24周或之后达到e200拷贝/mL的时间。 2.比较治疗方案之间的安全性，安全性定义为至首次出现3级或4级体征、症状或实验室检查异常的时间，至少比基线时高1级。 3.比较治疗方案之间的耐受性，耐受性定义为初始治疗方案中一种或多种药物发生变化的时间