A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 657
- 试验地点
- 15
- 主要终点
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
研究概览
简要总结
This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive 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
- •Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
- •Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
- •Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula
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 subject study compliance
- •Females who are pregnant (as confirmed by positive serum pregnancy test)
- •Females who are breastfeeding
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
B/F/TAF
B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks.
干预措施: B/F/TAF (Drug)
B/F/TAF
B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks.
干预措施: DTG Placebo (Drug)
B/F/TAF
B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks.
干预措施: F/TAF Placebo (Drug)
DTG + F/TAF
DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.
干预措施: DTG (Drug)
DTG + F/TAF
DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.
干预措施: F/TAF (Drug)
DTG + F/TAF
DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.
干预措施: B/F/TAF Placebo (Drug)
Open-label Phase B/F/TAF from B/F/TAF
After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.
干预措施: B/F/TAF (Drug)
Open-label Phase B/F/TAF from DTG + F/TAF
After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead 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 Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the 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
- Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm(Week 48)
- Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm(Week 96)
- Change From Baseline in log10 HIV-1 RNA at Week 96(Baseline, Week 96)
- Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm(Week 144)
- Change From Baseline in log10 HIV-1 RNA at Week 48(Baseline, Week 48)
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm(Week 144)
- Change From Baseline in log10 HIV-1 RNA at Week 144(Baseline, Week 144)
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm(Week 96)
- 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)
- Change From Baseline in CD4+ Cell Count at Week 144(Baseline, Week 144)
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm(Baseline, open-label Week 48)
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm(Baseline, open-label Week 48)
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm(Baseline, open-label Week 96)
- Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm(Baseline, open-label Week 96)
- Change From Baseline in CD4+ Cell Count at Week 48 Open-Label(Baseline, open-label Week 48)
- Change From Baseline in CD4+ Cell Count at Week 96 Open-Label(Baseline, open-label Week 96)