NCT01459575已完成不适用
Unboosted Atazanavir as Initial ART Therapy in China
National Center for AIDS/STD Control and Prevention, China CDC1 个研究点 分布在 1 个国家开始时间: 2005年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
This is an open-label, Pilot study.The study hypothesis is that the feasibility and efficacy of a non-boosted ATV based HAART will be well as the first line treatment in a Chinese resource-limited setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •The subject should have established HIV infection more than 6 month.
- •Qualifying plasma HIV RNA ≥ 2,000 c/mL and a CD4 cell count within 100 - 350 cells/mm3
- •≥16 years of age
- •Both females of child-bearing potential and males must utilize effective barrier contraception - other contraception in addition to barrier methods are permitted
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
排除标准
- •Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
- •Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
- •History of hemophilia
- •Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes are < 3 times the upper limit of normal.
- •Presence of cardiomyopathy.
- •A history of arrhythmia or clinical symptoms potentially related to heart block or second / third degree heart block.
- •Inability to tolerate oral medication
- •Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
研究者
NCAIDS
National Center for AIDS/STD Control and Prevention
National Center for AIDS/STD Control and Prevention, China CDC
研究点 (1)
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