NL-OMON39957已完成4 期
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 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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
研究者
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