URIDINE SUPPLEMENTATION FOR TREATMENT OF 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NucleomaxX的形式补充尿苷，用于治疗HIV相关性脂肪萎缩。NucleomaxX是欧洲的一种食品补充剂，在美国被认为是一种实验性药物。全国共有164名受试者(当地最多10名)将被随机服用NucleomaxX或安慰剂48周，并以标准化的方式观察疗效和毒性。这项研究将检验每隔一天服用3次36克(1包)的Nucleomax X对接受稳定的抗逆转录病毒治疗的人类免疫缺陷病毒(HIV)感染者的肢体脂肪的影响。这些受试者接受了包含司他夫定(D4T)或齐多夫定(ZDV)的稳定抗逆转录病毒治疗，同时接受了其他抗逆转录病毒药物的治疗。这项研究还将评估NucleomaxX的安全性和耐受性。DEXA扫描将在威斯康星大学综合临床研究中心进行，所有其他研究程序将在威斯康星州大学艾滋病临床试验单位进行。

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 treatment of HIV-associated lipoatrophy. NucleomaxX is a food supplement in Europe, which is considered an experimental drug in the U.S. A total of 164 subjects nationally (up to 10 locally) will be randomized to NucleomaxX or placebo for 48 weeks, and followed in a standardized fashion for efficacy and toxicity. This study will examine the effect of NucleomaxX at a dose of 36 grams (1 packet) 3 times a day every other day on limb fat measured by DEXA (dual-energy x-ray absorptiometry) in human immunodeficiency virus (HIV)-infected subjects receiving stable antiretroviral therapy containing stavudine (d4T) or zidovudine (ZDV) in combination with other antiretroviral drugs. The study also will assess the safety and tolerability of NucleomaxX. The DEXA scans will be done at the UW General Clinical Research Center, and all other study procedures will be done at the UW AIDS Clinical Trials Unit.