ACTG A5229:TRIAL OF URIDINE SUPPLEMENTATION

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。子项目及 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相关的脂肪萎缩。受试者将接受为期48周的设盲研究治疗。本研究将检查NucleomaxX对接受含d4 T或ZDV的稳定抗逆转录病毒治疗的HIV-1感染受试者肢体脂肪的影响。该研究还将评估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、临床脂肪萎缩且入组研究前胸苷NRTI（ZDV或d4 T）治疗累积持续时间至少24周的患者可入组本研究。受试者的血浆HIV-1 RNA水平必须≥ 5000拷贝/mL，并且在进入研究前至少连续12周接受稳定的含胸苷类似物的抗逆转录病毒治疗方案，在进入研究时没有计划在研究期间显著改变ART。本研究不提供抗逆转录病毒药物。 在研究入组时，164例受试者将以1：1的比例随机分配至以下任一组： A组： NucleomaxX：一袋（36克），每日三次，隔日口服 B组： NucleomaxX的安慰剂：一袋（36克）口服，每天三次，每隔一天。 这种隔日给药将持续至第336天（48周）。 如果在一天内（第一个24小时）没有服用所有三个小袋，则可以在第二天（第二个24小时）服用未使用的小袋。 未在2天（48小时）内服用的未使用的小袋被视为漏服剂量，必须在下次访视时返还给诊所。受试者在任何24小时内不得接受超过3次给药，每次给药之间必须等待至少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.