A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 567
- 试验地点
- 80
- 主要终点
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
研究概览
简要总结
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The ability to understand and sign a written informed consent form
- •On antiretroviral regimen containing ABC/3TC FDC in combination with one 3rd agent for ≥ 6 consecutive months prior to screening
- •Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and without experiencing two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year
- •Plasma HIV-1 RNA should be < 50 copies/mL at the screening visit
- •Normal ECG
- •Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft Gault formula for creatinine clearance
- •Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- •Adequate hematologic function
- •Serum amylase ≤ 5 × ULN
- •Females of childbearing potential and males must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
排除标准
- •A new AIDS-defining condition diagnosed within the 30 days prior to screening
- •Hepatitis B surface antigen (HBsAg) positive
- •Individuals experiencing decompensated cirrhosis
- •Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg, osteoporosis)
- •Pregnant or lactating females
- •Have an implanted defibrillator or pacemaker
- •Current alcohol or substance use judged by the investigator to potentially interfere with study compliance
- •A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
- •Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit
- •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
- •Participation in any other clinical trial (including observational trials) without prior approval
- •Medications excluded due to the potential for interaction with emtricitabine (FTC), TAF, ABC or 3TC
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
F/TAF (Double-Blind)
F/TAF + ABC/3TC placebo + allowed 3rd antiretroviral (ARV) agent for 96 weeks
After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
干预措施: F/TAF (Drug)
F/TAF (Double-Blind)
F/TAF + ABC/3TC placebo + allowed 3rd antiretroviral (ARV) agent for 96 weeks
After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
干预措施: ABC/3TC Placebo (Drug)
F/TAF (Double-Blind)
F/TAF + ABC/3TC placebo + allowed 3rd antiretroviral (ARV) agent for 96 weeks
After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
干预措施: 3rd ARV agent (Drug)
ABC/3TC (Double-Blind)
ABC/3TC + F/TAF placebo + allowed 3rd ARV agent for 96 weeks
After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
干预措施: ABC/3TC (Drug)
ABC/3TC (Double-Blind)
ABC/3TC + F/TAF placebo + allowed 3rd ARV agent for 96 weeks
After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
干预措施: F/TAF Placebo (Drug)
ABC/3TC (Double-Blind)
ABC/3TC + F/TAF placebo + allowed 3rd ARV agent for 96 weeks
After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
干预措施: 3rd ARV agent (Drug)
Open-Label F/TAF
After the unblinding visit, in countries where F/TAF FDC is not commercially available, participants (except in certain countries such as the UK) will be given the option to receive open-label F/TAF (200/10 mg or 200/25 mg) FDC and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.
干预措施: F/TAF (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
时间窗: Week 48
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
次要结局
- Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm(Week 48)
- Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm(Week 48)
- Change From Baseline in CD4 Cell Count at Week 96(Baseline; Week 96)
- Percent Change From Baseline in Spine BMD at Week 96(Baseline; Week 96)
- Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm(Week 96)
- Change From Baseline in CD4 Cell Count at Week 48(Baseline; Week 48)
- Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48(Baseline; Week 48)
- Percent Change From Baseline in Hip BMD at Week 96(Baseline; Week 96)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm(Week 96)
- Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm(Week 96)
- Percent Change From Baseline in Spine BMD at Week 48(Baseline; Week 48)