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).

这个子项目是众多研究子项目之一