EUCTR2006-006716-30-IT进行中（未招募）1 期
Randomized, controlled, multicentric trial to evaluate efficacy and safety of the switch from a LPV/r based therapy to an ATV/r or a NVP based treatment in association with ABC/3TC, in HIV patient with undetectable viral load
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点目标入组 200 人开始时间: 2007年2月5日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •?Male and female subjects between 18 and 65 years of age inclusive;
- •?Informed consent ;
- •?HIV-1 infected patients ;
- •?Actual treatment with a first/second line HAART with LPV/r and 2 NRTI longer than 6 months;
- •?Viral load suppression (HIV-1 <50 copies/ml) for at least 6 months before entry the study;
- •?Any CD4 count with the exception of women with more than 250 CD4/ml;
- •?Stable clinical conditions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Incapacity to give/ maintain the informed consent;
- •?Active opportunistic disease, neoplasm, acute viral hepatitis, IDU, alcoholism;
- •?Previous NNRTI treatment discontinued for virologic failure;
- •?Previous treatment with NVP interrupted due to intolerance and/or toxicity;
- •?Previous treatment with ABC interrupted due to virologic failure, intolerance and/or toxicity;
- •?Female patient of child bearing potential who:
- •oHas a positive serum pregnancy test at screening or during the study,
- •oIs breast feeding,
- •oIs planning to become pregnant,
- •oIs not willing to use barrier method protection
研究者
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