EUCTR2014-003052-31-ES进行中（未招募）1 期
A Phase 3, randomized, active-controlled, open-label study to evaluate 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 R&D, Ireland0 个研究点目标入组 660 人开始时间: 2014年11月4日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
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
- •- 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. Participants treated with the combination of DRV + COBI + FTC/TDF and completing the GS-US-216-0130 (NCT01440569) study, and who are fulfilling the present protocol criteria, will be given the option to participate in this study;
- •- On-treatment plasma human immunodeficiency virus type 1 ribonucleic acid (HIV-1 RNA) concentrations less than (<) 50 copies per milliliter (copies/mL) or HIV-1 RNA undetectable by a local HIV-1 RNA test for at least 6 consecutive months prior to the Screening visit and have HIV-1 RNA <50 copies/mL at the Screening visit;
- •- A single virologic elevation of greater than or equal to (>=) 50 copies/mL after previously reaching viral suppression within 6 months prior to Screening is 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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- A new acquired immunodeficiency syndrome (AIDS) - defining condition diagnosed within the 30 days prior to Screening
- •- Proven or suspected acute hepatitis within 30 days prior to study entry
- •- 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
- •- Hepatitis B surface antigen (HBsAg) positive
- •- Participants with cirrhosis as diagnosed based on local practices. As conventional ultrasound might not allow to adequately rule out liver cirrhosis, the use of other means for specific liver fibrosis staging is preferred
研究者
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