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.

这个子项目是许多研究子项目中的一个 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。 A5229是一项II/III期、随机、双盲、安慰剂对照研究，以NucleomaxX？的形式补充尿苷治疗HIV相关的脂肪萎缩。本研究将检查NucleomaxX对接受含司他夫定（d4 T）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，将入组164例受试者（每组82例）。受试者将接受9次研究访视，治疗48周。 受试者将接受体格检查、血液采样、双能X线吸收测定法（DEXA）扫描、体型/身体图像和饮食评估。