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：
9979844
负责人：
CHRISTINA M WYATT
金额：
$ 40.41万
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 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9979844
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 Inflammation 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 clinically relevant design follow-up high risk immune function mortality nephrotoxicity post gamma-globulins predictive modeling preservation prospective randomized trial rate of change success 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 感染与慢性肾病 (CKD) 风险增加有关，但人们对此知之甚少。 HIV 和抗逆转录病毒治疗 (ART) 对无症状 HIV 患者 CKD 的影响。对 CD4+ 细胞计数高的患者立即开始 ART 将导致早期改善 CKD 的临床相关标志物，但早期的肾脏益处将被长期的治疗所部分抵消。暴露于目前已确定具有肾毒性潜力的一线 ART 治疗方案中。抗逆转录病毒治疗战略时机 (START) 试验的辅助研究中的假设，随机试验调查早期 ART 与延迟 ART 对未接受治疗的个体的影响 CD4 > 500 个细胞/mm3 START 的随机设计提供了直接比较不同细胞的独特机会。开始 ART 的 HIV 感染者的肾功能变化和肾损伤标志物立即针对高 CD4 和延迟 ART 的类似个体预期记录。估计的肾小球滤过率以及存档的血浆和尿液样本的可用性将使我们能够评估立即 ART 对临床相关 CKD 结局的影响并细化现有风险 CD4 较高的 HIV 阳性个体的 CKD 预测评分。