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: 7717578
• 负责人: Michael Phillip Dube
• 金额: $ 0.11万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717578
• 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。 A5229是II/III期，随机，双盲，安慰剂对照的尿苷补充研究，以NucleMaxx的形式用于治疗HIV相关的脂肪植物。这项研究将检查核瘤对肢体脂肪的影响在接受HIV-1感染的受试者中接受含有Stavudine（D4T）或Zidovudine（ZDV）的稳定抗逆转录病毒疗法（ART）。该研究还将评估核敏量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（每只手臂82名）。受试者将进行9次研究访问，并进行48周的治疗。受试者将接受体格检查，血液采样，双能X射线绝对能力测定法（DEXA）扫描，身体形状/身体形象和饮食评估。