EUCTR2013-005487-26-DE进行中（未招募）1 期
A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults - Dose-finding study of BMS-955176 in HIV-1 Infected treatment-naive adults
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •- Men and non-pregnant women, at least 18 years of age
- •- Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week of an antiretroviral drug
- •Plasma HIV-1 RNA > or = to 1000 copies/mL
- •- CD4 T-cell count > 200 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 278
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •- Resistance or partial resistance to any study drug determined by tests at Screening
- •- Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors, (Please see protocol for further information on these exclusionary mutations)
- •- Chronic HBV/HCV
- •- Blood tests that inidcate normal liver function (see protocol)
- •- Hemoglobin < 8.0 g/dL and Platelets < 50,000 cells/mm3
研究者
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