URIDINE SUPPLEMENTATION FOR TREATMENT OF HIV LIPOATROPHY

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）将被随机分配至NucleomaxX或安慰剂组，持续48周，并以标准化方式随访疗效和毒性。 本研究将在接受稳定抗逆转录病毒治疗（含司他夫定（d4 T）或齐多夫定（ZDV）联合其他抗逆转录病毒药物）的人类免疫缺陷病毒（HIV）感染受试者中，检查NucleomaxX（剂量为36 g（1包），每日3次，隔日1次）对通过DEXA（双能X射线吸收测定法）测量的肢体脂肪的影响。该研究还将评估NucleomaxX的安全性和耐受性。DEXA扫描将在UW General Clinical Research Center进行，所有其他研究程序将在UW AIDS Clinical Trials Unit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.