ACTG A5229:TRIAL OF URIDINE SUPPLEMENTATION

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。受试者将接受为期48周的盲法研究治疗。这项研究将考察在接受含有d4T或ZDV的稳定抗逆转录病毒治疗的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。 HIV-1感染的男性和女性？18岁，有临床脂肪萎缩，在进入研究前至少接受胸腺嘧啶核苷NRTI(ZdV或d4T)治疗的累积持续时间至少24周，可纳入这项研究。受试者的血浆HIV-1RNA水平必须达到或等于5000拷贝/毫升，并在进入研究前至少连续12周接受稳定的含有胸苷类似物的抗逆转录病毒疗法，在研究进入时没有计划在研究期间大幅改变ART。该研究不会提供抗逆转录病毒药物。 在研究开始时，164名受试者将以1：1的比例随机分为以下几组： 手臂A： 每隔一天口服一次香包(36克)，每次三次 手臂B： Nucleomax X的安慰剂：一个香包(36克)，每隔一天口服三次。 这种每隔一天给药一次的情况将持续到第336天(48周)。 如果三个香包没有在一天内(第一个24小时内)取走，那么第二天(第二个24小时内)可以取走未使用的香包(S)。在两天内(48小时)内未服用的未使用的香包被视为错过了剂量，必须在下次就诊时退回诊所。受试者在任何24小时内不得服用超过三剂，并且每次服用之间必须等待至少4小时。

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. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of NucleomaxX on limb fat in HIV-1-infected subjects receiving stable antiretroviral therapy containing d4T or ZDV. The study also will assess the safety and tolerability of NucleomaxX in this population. HIV-1-infected men and women ?18 years of age, with clinical lipoatrophy and a cumulative duration of thymidine NRTI (ZDV or d4T) treatment of at least 24 weeks prior to study entry may be enrolled in this study. Subjects must have a plasma HIV-1 RNA level of or equal to 5000 copies/mL, and be receiving stable thymidine analogue-containing antiretroviral regimen for a minimum of 12 consecutive weeks prior to study entry, with no plan at study entry to significantly alter ART for the duration of the study. Antiretroviral drugs will not be provided by the study. At study entry, 164 subjects will be randomized 1:1 to one of the following: Arm A: NucleomaxX: One sachet (36 grams) orally three times per day, every other day Arm B: Placebo for NucleomaxX: One sachet (36 grams) orally three times per day, every other day. This every other day dosing will continue through day 336 (48 weeks). If all three sachets are not taken in one day (first 24 hour period), the unused sachet(s) can be taken the next day (second 24 hour period). Unused sachets not taken within the 2-day period (48 hours) are considered missed doses and must be returned to the clinic at the next visit. The subject must not take more than three doses in any 24 hour period and must wait at least 4 hours between taking each dose.