A PHASE II/III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF URIDINE

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。这项研究将考察在接受含有司他夫定(D4T)或齐多夫定(ZDV)的稳定抗逆转录病毒治疗(ART)的HIV-1感染者中，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。在全国范围内，将招收164名受试者(每支手臂82名)。受试者将接受9次为期48周的学习访问。受试者将接受体检、采血、双能X射线吸收法(DEXA)扫描、体型/体像和饮食评估。

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.