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 - AMBER

Janssen Sciences Ireland UC0 个研究点目标入组 670 人开始时间: 2015年6月15日最近更新: 2018年10月15日

适应症

试验速览

暂无简介。

•- Subject must be antiretroviral (ARV) treatment-naive; no prior use of any approved or experimental anti- human immunodeficiency virus (anti-HIV) drug for any length of time. Subjects treated with post-exposure prophylaxis and/or pre-exposure prophylaxis may be enrolled in the study if treatment stopped at least 30 days prior to Screening
•- 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 >=50 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

•- 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

发起方