MARCH 腎臓サブスタディ

基本情報

NCT ID: NCT01637259
ステータス: 完了
試験のフェーズ: 第4相
試験タイプ: 介入
目標被験者数: 76
治験依頼者名: Kirby Institute

概要

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).

対象疾患

ProteinuriaHIV

介入

arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors(DRUG)

Arm 2 boosted protease inhibitors and maraviroc(DRUG)

Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc(DRUG)

依頼者（Sponsor）

Kirby Institute(OTHER_GOV)

実施施設 (1)

独立行政法人国立病院機構　名古屋医療センター

Nagoya, Japan