CLINICAL TRIAL: TRIAL OF URIDINE SUPPLEMENTATION IN HIV LIPOATROPHY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 A5229是一项II/III期的随机、双盲、安慰剂对照研究，以Nucleomax X的形式补充尿苷，用于治疗HIV相关性脂肪萎缩。这项研究将考察接受包含司他夫定(Zerit？)或齐多夫定(Retrovir？)的稳定抗逆转录病毒疗法(ART)的HIV-1感染者的Nucleomax X对肢体脂肪的影响。这项研究还将评估NucleomaxX在该人群中的安全性和耐受性。这项研究将试图了解在HIV感染者中服用尿苷是否安全，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。尿苷是一种粉状营养食品补充剂，含有一种名为尿苷的物质。它是装在香包里的，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药物。

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.