A PHASE II/III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF URIDINE

尿苷 II/III 期、随机、双盲、安慰剂对照试验

• 批准号: 7606481
• 负责人: MICHAEL P DUBE
• 金额: $ 0.48万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606481
• 关键词: Blood specimen; Body Image; Computer Retrieval of Information on Scientific Projects Database; Dietary Assessment; Double-Blind Method; Enrollment; Fatty acid glycerol esters; Funding; Grant; HIV-1; Institution; Limb structure; Lipoatrophy; Phase; Population; Randomized; Research; Research Personnel; Resources; Safety; Scanning; Shapes; Source; Stavudine; Supplementation; United States National Institutes of Health; Upper arm; Uridine; Visit; Week; Zidovudine; antiretroviral therapy; double-blind placebo controlled trial; placebo controlled study

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. A5229 is a phase II/III, randomized, double-blind, placebo-controlled study of uridine supplementation in the form of NucleomaxX¿ for the treatment of HIV-associated lipoatrophy. This study will examine the effect of NucleomaxX on limb fat in HIV-1 infected subjects receiving stable antiretroviral therapy (ART) containing stavudine (d4T) or zidovudine (ZDV). The study will also assess the safety and tolerability of NucleomaxX in this population. Nationally, 164 subjects (82 per arm) will be enrolled. Subjects will have nine study visits with 48 weeks of treatment. Subjects will undergo physical exams, blood sampling, dual-energy x-ray absorptiometry (DEXA) scans, body shape/body image and dietary assessments.

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。子项目和 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。 A5229 是一项 II/III 期随机、双盲、安慰剂对照研究，研究以 NucleomaxX 形式补充尿苷用于治疗 HIV 相关脂肪萎缩。这项研究将检查 NucleomaxX 对接受含有司他夫定 (d4T) 或齐多夫定 (ZDV) 的稳定抗逆转录病毒治疗 (ART) 的 HIV-1 感染受试者的肢体脂肪的影响。 该研究还将评估 NucleomaxX 在该人群中的安全性和耐受性。 在全国范围内，将招募 164 名受试者（每组 82 名）。受试者将接受 9 次研究访问，为期 48 周的治疗。 受试者将接受体检、血液采样、双能 X 射线吸收测定法 (DEXA) 扫描、体形/身体形象和饮食评估。