A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of protease inhibitors to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml - RASSTER

niversitair Medisch Centrum Utrecht0 个研究点目标入组 24 人待定

概览

阶段: 4 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: niversitair Medisch Centrum Utrecht
入组人数: 24
状态: 已完成
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

待定

结束日期

待定

最后更新

2年前

研究类型

Interventional

研究者

发起方

niversitair Medisch Centrum Utrecht

入排标准

入选标准

•\-Age \>\= 18 years
•\-HIV\-1 infection
•\-Treatment with antiretroviral regimen containing lopinavir/ritonavir or atazanavir/ritonavir for at least the previous 3 months
•\-No other protease inhibitors besides lopinavir\-ritonavir or atazanavir/ritonavir in antiretroviral regimen
•\-Subjects must have a minimum period of viral suppression (plasma HIV\-RNA \<50 copies/ml) of 6 months
•\-Subjects will not have a history of virological failure on antiretroviral therapy
•\-Results of previous resistance testing allowing replacement of lopinavir\-ritonavir or atazanavir/ritonavir by raltegravir
•\-CD4\+ cell count \> 200 cells/µL
•\-Signed informed consent

排除标准

•\-Pregnancy
•\-Breastfeeding
•\-Raltegravir hypersensitivity
•\-Treatment of underlying malignancy
•\-Renal insufficiency requiring dialysis
•\-Acute or decompensated chronic hepatitis (Child\-Pugh score C)
•\-Modification of antiretroviral regimen in the previous 3 months

结局指标

主要结局

未指定

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