Impact of early antiretroviral therapy on kidney disease outcomes

早期抗逆转录病毒治疗对肾脏疾病结局的影响

基本信息

批准号：
10227168
负责人：
CHRISTINA M WYATT
金额：
$ 31.25万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10227168
关键词：
AIDS-Associated Nephropathy Acquired Immunodeficiency Syndrome Address Adult Age Albumins Albuminuria Ancillary Study Archives Benefits and Risks Biological Markers Black race CD4 Lymphocyte Count Cardiovascular Diseases Caring Cells Cessation of life Chronic Kidney Failure Clinical Cohort Studies Creatinine Data Diabetes Mellitus Disease Outcome Documentation End stage renal failure Event Exposure to Fumarates Future Glomerular Filtration Rate Goals HIV HIV Infections HIV Seropositivity HIV therapy Hypertension Incidence Individual Injury to Kidney Kidney Kidney Diseases Morbidity - disease rate National Institute of Allergy and Infectious Disease Nature Outcome Participant Patients Persons Plasma Protease Inhibitor Provider Randomized Regimen Renal function Research Risk Risk Factors Ritonavir Specimen Subgroup Tenofovir Testing Tubular formation Urine Visit antiretroviral therapy asymptomatic HIV infection base biological specimen archives clinically relevant design follow-up high risk immune function mortality nephrotoxicity post gamma-globulins predictive modeling preservation prospective randomized trial rate of change success systemic inflammatory response treatment trial

项目摘要

Project Abstract HIV infection is associated with an increased risk of chronic kidney disease (CKD). Little is known about the contribution of HIV and antiretroviral therapy (ART) to CKD in asymptomatic HIV. We hypothesize that immediate initiation of ART in patients with high CD4+ cell counts will result in early improvements in clinically relevant markers of CKD, but that the early renal benefits will be partially offset by prolonged exposure to current first-line ART regimens with established nephrotoxic potential. We will test this hypothesis in an ancillary study to the Strategic Timing of AntiRetroviral Treatment (START) trial, a randomized trial investigating the impact of early versus deferred ART in treatment-naïve individuals with CD4 > 500 cells/mm3. The randomized design of START offers a unique opportunity to directly compare the change in kidney function and markers of kidney injury between HIV-infected individuals who initiate ART immediately at high CD4 and similar individuals in whom ART is deferred. The prospective documentation of estimated glomerular filtration rate and availability of archived plasma and urine specimens will allow us to evaluate the impact of immediate ART on clinically relevant CKD outcomes and to refine existing risk scores for the prediction of CKD in HIV-positive individuals with high CD4.

项目摘要 HIV感染与慢性肾脏疾病（CKD）的风险增加有关。关于 HIV和抗逆转录病毒疗法（ART）对非对称HIV中CKD的贡献。我们假设这一点高CD4+细胞计数患者的ART立即主动，将早期改善 CKD的临床相关标记，但延长的肾脏福利将部分抵消暴露于具有确定的肾毒性潜力的当前一线艺术方案。我们将测试这个假设在一项辅助研究抗逆转录病毒治疗（Start）试验的战略时机的辅助研究中随机试验调查了早期与递延艺术在没有治疗的人中的影响 CD4> 500个单元/mm3。开始的随机设计提供了一个独特的机会，可以直接比较肾脏功能的改变和发起艺术的艾滋病毒感染者之间的肾脏损伤标记立即在高CD4和类似的艺术中被推迟的人。潜在的文件估计的肾小球过滤率以及存档等离子体和尿液标本的可用性将使我们评估直接艺术对临床相关的CKD结果的影响，并完善现有风险在艾滋病毒阳性较高的CD4的HIV阳性个体中预测CKD的评分。