NCT03405935已完成3 期
A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 25
- 主要终点
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm
研究概览
简要总结
The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine [FTC]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 [NCT02616783]) for ≥ 3 months
- •Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 [NCT02616783]) for the last 2 visits preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
- •Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
排除标准
- •An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
- •Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
- •Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance
- •Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
B/F/TAF
Experimental
B/F/TAF FDC for at least 96 weeks.
干预措施: B/F/TAF (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm
时间窗: Week 24
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.
次要结局
- Change From Baseline in CD4 Percentage at Week 24(Baseline, Week 24)
- Percentage of Participants Experiencing AEs Through Week 48(First dose date Up to Week 48)
- Change From Baseline in CD4 Cell Count at Week 48(Baseline, Week 48)
- Change From Baseline in CD4 Cell Count at Week 96(Baseline, Week 96)
- Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24(First dose date up to Week 24)
- Percentage of Participants Experiencing AEs Through Week 72(First dose date Up to Week 72)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm(Week 48)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm(Week 72)
- Change From Baseline in CD4 Cell Count at Week 24(Baseline, Week 24)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA-Defined Snapshot Algorithm(Week 96)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Failure Approach(Week 24)
- Percentage of Participants Experiencing AEs Through Week 96(First dose date Up to Week 96)
- Change From Baseline in CD4 Cell Count at Week 72(Baseline, Week 72)
- Change From Baseline in CD4 Percentage at Week 48(Baseline, Week 48)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Failure Approach(Week 96)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Excluded Approach(Week 24)
- Change From Baseline in CD4 Percentage at Week 72(Baseline, Week 72)
- Change From Baseline in CD4 Percentage at Week 96(Baseline, Week 96)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Failure Approach(Week 48)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Excluded Approach(Week 72)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Excluded Approach(Week 48)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Failure Approach(Week 72)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Excluded Approach(Week 96)
研究者
研究点 (25)
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