A PHASE IIIB, RANDOMIZED, TRIAL OF OPEN-LABEL EFAVIRENZ OR ATAZANAVIR WITH RI

开放标签依非韦伦或阿扎那韦联合 RI 的 IIIB 期随机试验

• 批准号: 8167085
• 负责人: ARDIS A MOE
• 金额: $ 13.45万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167085
• 关键词: Atazanavir; Bone Density; Computer Retrieval of Information on Scientific Projects Database; DEXA; Development; Failure; Fatty acid glycerol esters; Funding; Grant; HIV-1; Hip region structure; Institution; Laboratories; Limb structure; Metabolic; Peripheral; Pharmaceutical Preparations; Phase; Plasma; RNA; Regimen; Research; Research Personnel; Resources; Safety; Signs and Symptoms; Source; Time; Treatment Protocols; United States National Institutes of Health; Vertebral column; arm; efavirenz; open label; randomized trial

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. SPECIFIC AIMS: Main Study: 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 =1000 copies/mL at or after 16 weeks and before 24 weeks or =200 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. Metabolic Sub-Study: The primary objectives are: 1. To assess changes within treatment arms in peripheral fat changes (limb fat) after the initiation of an ARV regimen containing ABC/3TC or FTC/TDF (Arms B/D or A/C). 2. To compare the effects of initiation of an ARV regimen containing ABC/3TC with those of a regimen containing FTC/TDF on bone mineral density (BMD), as assessed by lumbar spine and hip DEXA (Arms B/D versus A/C).

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 具体目标： 主要研究： 三个主要目标是： 1. 比较病毒学失败的治疗方案之间的病毒学疗效，病毒学失败定义为在 16 周或之后和 24 周之前确认血浆 HIV-1 RNA 水平 = 1000 拷贝/mL 的时间，或在 24 周或之后 = 200 拷贝/mL 的时间。 2. 比较治疗方案之间的安全性，安全性定义为首次出现 3 级或 4 级体征、症状或实验室异常（比基线高至少一级）的时间。 3. 比较不同方案之间的耐受性，耐受性定义为初始治疗方案中更换一种或多种药物的时间。 代谢子研究： 主要目标是： 1. 评估开始包含 ABC/3TC 或 FTC/TDF 的 ARV 治疗方案（B/D 组或 A/C 组）后治疗组内外周脂肪变化（肢体脂肪）的变化。 2. 通过腰椎和髋部 DEXA 评估（手臂 B/D 与 A/C ）。