EUCTR2011-003298-26-NL进行中（未招募）不适用
A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of lopinavir-ritonavir to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml - RASSTER
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age = 18 years
- •-HIV-1 infection
- •-Treatment with antiretroviral regimen containing lopinavir-ritonavir for at least the previous 3 months
- •-No other protease inhibitors besides lopinavir-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 by raltegravir
- •-CD4+ cell count > 200 cells/µL
- •-Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
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
研究者
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