CLINICAL TRIAL: TRIAL OF URIDINE SUPPLEMENTATION IN HIV LIPOATROPHY

临床试验：补充尿苷治疗 HIV 脂肪萎缩的试验

• 批准号: 7718655
• 负责人: DAVID WININGER
• 金额: $ 2.45万
• 依托单位: OHIO STATE UNIVERSITY
• 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/7718655
• 关键词: Buttocks; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Double-Blind Method; Europe; Face; Fatty acid glycerol esters; Food Supplements; Funding; Grant; HIV-1; Institution; Juice; Leg; Limb structure; Lipoatrophy; Milk; Nutritional; Persons; Pharmaceutical Preparations; Phase; Population; Powder dose form; Randomized; Research; Research Personnel; Resources; Retrovir; Safety; Source; Stavudine; Supplementation; United States Food and Drug Administration; United States National Institutes of Health; Upper arm; Uridine; Water; Zidovudine; antiretroviral therapy; 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 NucleomaxXfor 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 (Zerit¿) or zidovudine (Retrovir¿). The study will also assess the safety and tolerability of NucleomaxX in this population. This study will try to see if taking uridine is safe in HIV-infected persons and if it will reverse loss of fat in the face, arms, legs, or buttocks. The study will also try to see how well uridine is tolerated. Uridine is a powdered nutritional food supplement that contains a substance called uridine. It comes in a sachet (packet) and needs to be mixed in with juice, milk, or water. Uridine is used in Europe as a food supplement but is not approved by the U.S. Food and Drug Administration (FDA) and is considered an experimental drug in the U.S.

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Nucleomax X的形式补充尿苷治疗HIV相关脂肪萎缩。这项研究将检查NucleomaxX对接受含司他夫定（Zerit）或齐多夫定（Retrovir）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。这项研究将试图了解服用尿苷对HIV感染者是否安全，以及它是否会逆转面部，手臂，腿部或臀部的脂肪损失。这项研究还将试图了解尿苷的耐受性如何。 尿苷是一种粉状营养食品补充剂，含有一种称为尿苷的物质。它装在一个小袋里，需要和果汁、牛奶或水混合。尿苷在欧洲被用作食品补充剂，但没有得到美国食品和药物管理局（FDA）的批准，在美国被认为是一种实验性药物。