A PHASE II/III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIA
A PHASE II/III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIA
批准号:
7952242
负责人:
ERIC S DAAR
金额:
$0.91万
依托单位国家:
美国
项目类别:
财政年份:
2008
资助国家:
美国
项目状态:
已结题
起止时间:
2008-12-01 至 2009-11-30
关键词:
AdherenceAdipose tissueAnti-Retroviral AgentsButtocksClinicalClinical ResearchComplicationComputer Retrieval of Information on Scientific Projects DatabaseDevelopmentDisincentiveDistressDouble-Blind MethodFaceFatty acid glycerol estersFundingGrantHIVHypersensitivityInstitutionLegLipoatrophyMitochondrial DNANucleosidesPeripheralPersonsPhasePlacebo ControlQuality of lifeRandomizedReactionReportingResearchResearch PersonnelResistanceResourcesSourceStavudineTenofovirThymidineUnited States National Institutes of HealthUpper armUridineZidovudineabacaviranalogcardiovascular disorder riskexperiencenucleoside analogsubcutaneoussuccessful intervention
中文摘要
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。
艾滋病毒的管理因脂肪萎缩而变得复杂,这是抗逆转录病毒治疗的一种令人痛苦的长期并发症,与生活质量下降有关,不愿坚持治疗,以及可能增加心血管疾病的风险。脂肪萎缩的一种被提出的机制是胸苷类似核苷类似物(齐多夫定或司他夫定[d4T])导致皮下脂肪组织线粒体DNA耗竭。不幸的是,目前还没有治疗临床脂肪萎缩的方法。到目前为止,有几种策略未能成功扭转这种状况。最成功的干预措施是用阿巴卡韦取代d4T。然而,约5%的人对阿巴卡韦有严重的过敏反应。最近的研究报告了用替诺福韦替代d4T或ZDV后,周围脂肪的类似改善。此外,由于潜在的核苷耐药性,许多有艺术经验的人不适合这种核苷替代策略。
这项研究的目的是观察服用尿苷补充剂(NecleomaxX)对艾滋病毒感染者是否安全,以及它是否会逆转面部、手臂、腿部和臀部的脂肪损失。
英文摘要
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.
The management of HIV has been complicated by lipoatrophy, a distressing long-term complication of Antiretroviral treatment associated with decreased quality of life, disincentive for adherence to therapy, as well as possibly increased risk of cardiovascular disease. A proposed mechanism for the development of lipoatrophy is mitochondrial DNA-depletion in subcutaneous adipose tissue caused by thymidine analogue nucleoside analogues (zidovudine [ZDV] or stavudine [d4T]). Unfortunately, no therapy is available for clinical lipoatrophy. To date, several strategies have been unsuccessful in reversing this condition. The most successful intervention has been the replacement of d4T with abacavir. However, about 5% of people experience serious hypersensitivity reactions on abacavir. Recent studies have reported similar improvement in peripheral fat after replacement of d4T or ZDV with tenofovir. Additionally, many ART-experienced persons are not suitable candidates for this nucleoside substitution strategydue to underlying necleoside resistance.
The purpose of this study is to see of taking a uridine supplement (NecleomaxX) is safe in HIV infected persons and if it will reverse loss of fat in the face, arms, legs, and buttocks.
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