NCT00234962终止4 期
Factors Associated With Adherence in a Cohort of HIV Positive Subjects on a First Time PI Containing HAART Regimen: Observational Study of the Impact of Adherence on Viral Load for a HAART Regimen Containing Kaletra vs Other Selected PI Containing HAART.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Antiviral efficacy by HIV RNA
研究概览
简要总结
The purpose of this study is to evaluate the effects of adherence on HIV antiviral response to treatment regimens containing Kaletra or other HIV protease inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is documented HIV positive
- •Subject is greater than or equal to 18 years of age.
- •Subject currently on a regimen of either NNRTI + 2 Nucleoside Reverse Transcriptase Inhibitors NRTIs), two or three NRTIs who have failed regimen as evidenced by two consecutive viral loads with values over 1,000 copies/mL, the last one within the last three months, or
- •Naïve subjects to ARV regimen who are required to begin a PI containing HAART regimen, or
- •Subjects who have become intolerant to their current antiretroviral regimen and are required to be changed to a first time PI containing HAART regimen.
- •Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin >8.0 g/dL; Absolute neutrophil count >750 cells/mL; Platelet count >20,000/mL; ALT or AST <3 x Upper Limit of Normal (ULN); Creatinine <1.5 x ULN; Triglycerides <750 mg/dL.
- •Subjects have no have evidence of grade III or IV adverse event or laboratory abnormality.
排除标准
- 未提供
结局指标
主要结局
Antiviral efficacy by HIV RNA
次要结局
- Treatment related discontinuations, predictors of adherence
研究者
研究点 (2)
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