A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 567
- 主要终点
- Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.
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
- •Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
- •Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
- •HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.
- •Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months 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).
- •Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.
排除标准
- •Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
- •Active tuberculosis infection.
- •Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
- •Females who are pregnant.
- •Females who are breastfeeding.
- •Acute hepatitis in the 30 days prior to study entry.
- •Chronic Hepatitis B Virus (HBV) infection.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Blinded Phase: B/F/TAF
B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks
干预措施: B/F/TAF (Drug)
Blinded Phase: B/F/TAF
B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks
干预措施: ABC/DTG/3TC Placebo (Drug)
Blinded Phase: ABC/DTG/3TC
ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
干预措施: ABC/DTG/3TC (Drug)
Blinded Phase: ABC/DTG/3TC
ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
干预措施: B/F/TAF Placebo (Drug)
Open-Label Phase
At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.
干预措施: B/F/TAF (Drug)
结局指标
主要结局
Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US 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
- Spine Bone Mineral Density (BMD) at Baseline(Baseline)
- Percentage Change From Baseline in Spine BMD at Week 48(Baseline; Week 48)
- Hip Bone Mineral Density at Baseline(Baseline)
- Percentage Change From Baseline in Hip BMD at Week 48(Baseline; Week 48)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm(Week 48)
- Change From Baseline in CD4+ Cell Count at Week 48(Baseline; Week 48)