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临床试验/NCT01637259
NCT01637259已完成4 期

Maraviroc Switch Collaborative Study Renal Substudy

Kirby Institute15 个研究点 分布在 8 个国家目标入组 76 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
76
试验地点
15
主要终点
changes in proteinuria and albuminuria between baseline and week 96

研究概览

简要总结

Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV. Antiretroviral therapy associated renal dysfunction has been predominantly described in terms of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur in the absence of significant reductions in eGFR. This substudy is an exploration of changes in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and safety of MVC as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART).

详细描述

The aim of this substudy of MARCH is to characterize the changes in protein and salt excretion through the kidney utilising the randomised arms of the parent study MARCH. The investigators hypothesize there will be an improvement in proteinuria in those switching to maraviroc containing regimens.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of written, informed consent for participation in the substudy
  • Enrolled into the substudy either at or before the week 0 visit of the main study

排除标准

  • 未提供

研究组 & 干预措施

NRTI + PI

Active Comparator

arm 1

干预措施: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors (Drug)

PI + maraviroc

Active Comparator

arm 2

干预措施: Arm 2 boosted protease inhibitors and maraviroc (Drug)

NRTI + maraviroc

Active Comparator

arm 3

干预措施: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc (Drug)

结局指标

主要结局

changes in proteinuria and albuminuria between baseline and week 96

时间窗: 96 weeks

To compare the change in protein and albumin excretion as measured by the urine PCR and ACR through the kidneys between the randomised and standard of care (control) arm of MARCH.

次要结局

  • changes in renal tubular function between baseline and week 96(96 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (15)

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