EUCTR2005-001895-11-IT进行中(未招募)不适用
A 96 Week Phase IIIB Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavir ATV/RTV with Lopinavir/ritonavir LPV/RTV , Each in Combination with Fixed Dose Tenofovir-Emtricitabine in HIV-1 infected treatment naive subjects. - Castle
BRISTOL-M.SQUIBB0 个研究点目标入组 1,200 人开始时间: 2006年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,200
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
- •Antiretroviral-na ve HIV-1 infected subjects with no contraindication to study medications. Subjects must have a confirmed plasma HIV-1 RNA level 61619;2000 c/mL and an absolute CD4 count 61619; 50 cells/mm3.
- •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
- •Woman who are pregnant or breast feeding; Suspected primary acute HIV infection; Any antiretroviral therapy within 30 days prior to screening; Prior antiviral therapy / 1 week; Presence of cardiomiopathy or any significant cardiovascular disease; Screening laboratory values measured as follows calculated creatinine clearance 60 mL/min; total serum lipase / 1.4 times the upper limit of normal; liver enzymes AST,ALT / 5 times the upper limit of normal; total serum bilirubin / 1.5 times the upper limit of normal.
研究者
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