EUCTR2015-000754-38-BE进行中（未招募）1 期
A Phase 3, randomized, active-controlled, double-blind study to evaluate efficacy and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once daily fixed dose combination regimen versus a regimen consisting of darunavir/cobicistat fixed dose combination coadministered with emtricitabine/tenofovir disoproxil fumarate fixed dose combination in antiretroviral treatment-naïve human immunodeficiency virus type 1 infected subjects
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 670
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
入选标准
- •- Subject must be antiretroviral (ARV) treatment-naive (never treated with an ARV including post-exposure prophylaxis and pre-exposure prophylaxis); no prior use of any approved or experimental anti- human immunodeficiency virus (anti-HIV) drug for any length of time.
- •- Screening plasma HIV-1 ribonucleic acid (RNA) level greater than or equal to >=1,000 copies per milliliter (copies/mL)
- •- Cluster of Differentiation 4+ (CD4+) cell count >50 cells/microliter (cells/mcL)
- •- Screening HIV-1 genotype report must show full sensitivity to DRV, TDF and FTC
- •- Screening eGFRcreatinine >=70 mL/min according to the Cockcroft-Gault formula for creatinine clearance
- •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 663
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Subject has been diagnosed with a new acquired immunodeficiency syndrome (AIDS)-defining condition within the 30 days prior to screening
- •- Subject has proven or suspected acute hepatitis within 30 days prior to screening
- •- Subject is hepatitis C or hepatitis B positive
- •- Subject has a history of cirrhosis
研究者
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