EUCTR2004-002880-26-DE进行中（未招募）不适用
A Phase IV, Multi-center, Cross-sectional study to evaluate the I50L substitution among subjects experiencing virologic failure on a HAART regimen containing atazanavir (ATV)Protocol: version 2.0, 2004-07-14Amendment 1: version 1.0, 2005-01-04
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
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
- •- Subject must be able to understand the informed consent and to provide written
- •informed consent;
- •- Subjects currently on an antiretroviral regimen containing ATV with either: 1) a confirmed virologic rebound (an HIV RNA = 1000 copies/mL, after achieving a value
- •< 400 copies/mL on at least two consecutive measurements) or 2) an HIV RNA = 1000 copies/mL after 24 weeks of therapy. In both cases, HIV RNA = 1000 copies/mL must be confirmed by screening/enrollment measurement within 14-90 days of the first HIV RNA value. The subject must be on the ATV-containing HAART regimen at the time of enrollment. The confirming viral load at screening/enrollment must be plasma HIV-1 RNA level obtained by using the Roche Amplicor Ultrasensitive Assay (Version 1.5) (or other approved assay as agreed upon by the medical monitor).
- •- Men and women = 18 years of age.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- VL <1000 c/mL at the screening visit.
- •- Individuals exhibiting virologic failure on a HAART regimen that does not include
- •- Subjects who are incapable to give informed consent.
研究者
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