EUCTR2004-000441-38-AT进行中（未招募）1 期
arge, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study) - SMART
ational Institute of Allergy and Infectious Diseases, National Institutes of Health0 个研究点目标入组 6,000 人开始时间: 2005年3月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,000
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
- •1. Signed informed consent
- •2. Evidence of HIV infection (positive ELISA and Western Blot and/or documented history of measurable HIV RNA)
- •3. Age > 13 years (in effect 18 years at most sites)
- •4. Current CD4+ cell count > 350 cells/mm3 (within 45 days prior to randomization)
- •5. Willing to initiate, modify, or stop antiretroviral therapy, in accordance with the randomized assignment
- •6. If participating in sexual activity that could lead to pregnancy, willingness to use acceptable contraception methods
- •Are the trial subjects under 18? yes
- •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
- •1. Current participation in the CPCRA FIRST, MDR-HIV or another study which is not consistent with one of the treatment groups in the SMART study (e.g., ESPRIT or SILCAAT).
- •2. Current pregnancy or breastfeeding
研究者
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