NL-OMON38997撤回4 期
A prospective open-label study to investigate the effects of switching to a darunavir based regimen on low level viremia, immune activation and neurocognitive performance in patients on antiviral therapy. - LOWERIT
niversitair Medisch Centrum Utrecht0 个研究点目标入组 65 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 65
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
- •a. Using cART for at least 48 weeks, including 2 NRTIs + 1 NNRTI or 1 PI
- •b. Low level viremia (2 or more HIV viral loads between 50-1000 cp/mL in a year, without Target Not Detected (TND) in between
- •c. Viral load <200 cp/mL at at least one measurement since starting cART.
排除标准
- •a. Presence of known pol major IAS mutations for darunavir (I47V; I50V; I54M/L; L76V; I84V)
- •b. Signs of opportunistic infections
- •c. Major suspicion of inadequate therapy adherence
- •d. Severe depression at screening (BDI score >30)
- •e. Severe hepatic impairment (Child-Pugh Class C)
研究者
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