A Phase 3, randomized, active-controlled, open-label study to evaluate the efficacy, safety and tolerability of switching to a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once-daily single-tablet regimen versus continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects.

Janssen Science Ireland Unlimited Company0 个研究点目标入组 1,100 人开始时间: 2014年10月10日最近更新: 2020年7月27日

试验速览

暂无简介。

•- Currently being treated with a stable antiretroviral (ARV) regimen consisting of a boosted protease inhibitor(limited to darunavir [DRV] or atazanavir with low dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv combined with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) only, for at least 6 consecutive months preceding the screening visit.
•- On-treatment plasma human immunodeficiency virus type 1 ribonucleic acid (HIV-1 RNA) concentrations less than (<) 50 copies per ml (copies/ml) or HIV-1 RNA undetectable by a local HIV-1 RNA test between 12 and 2 months prior to the Screening visit and have HIV-1 RNA <50 copies/ml at the Screening vist
•- A single virologic elevation of greater than or equal to (>=) 50 copies per ml after previously reaching viral suppression between 12 and 2 months prior to screening in acceptable, provided a subsequent test prior to Screening was <50 copies/ml
•- Absence of history of failure on DRV treatment and absence of DRV resistance-associated mutations (RAMs), if documented historical genotypes are available
•- Normal electrocardiogram (ECG) at Screening (or if abnormal, determined by the Investigator to be not clinically significant
•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 990
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

•1. A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening.
•2. Proven or suspected acute hepatitis within 30 days prior to study enter.
•3. Hepatitis C antibody positive; however, participants previously cured of hepatitis C virus (HCV) infection, with documented sustained virologic response, that is, undetectable HCV RNA 24 weeks after the last dose of HCV treatment, are allowed to participate.
•4. Hepatitis B surface antigen (HBsAg) positive.
•5. Participants with cirrhosis as diagnosed based on local practices.

发起方

Janssen Science Ireland Unlimited Company