NCT02397694已完成2 期
A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 主要终点
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.
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 naive (≤ 10 days of prior therapy with any antiretroviral agent)
- •Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
- •Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)
- •Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula
- •CD4+ cell count ≥ 200 cells/µL at screening
排除标准
- •A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol
- •Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)
- •Chronic hepatitis B virus (HBV) infection
- •Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)
- •Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
- •Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
BIC + F/TAF
Experimental
Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks.
- Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
干预措施: BIC (Drug)
BIC + F/TAF
Experimental
Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks.
- Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
干预措施: F/TAF (Drug)
BIC + F/TAF
Experimental
Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks.
- Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
干预措施: DTG Placebo (Drug)
BIC + F/TAF
Experimental
Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks.
- Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
干预措施: B/F/TAF (Drug)
DTG + F/TAF
Active Comparator
Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks.
- Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
干预措施: F/TAF (Drug)
DTG + F/TAF
Active Comparator
Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks.
- Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
干预措施: DTG (Drug)
DTG + F/TAF
Active Comparator
Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks.
- Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
干预措施: BIC Placebo (Drug)
DTG + F/TAF
Active Comparator
Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks.
- Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
干预措施: B/F/TAF (Drug)
Open Label Extension Phase
Experimental
After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF.
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 as Determined by the FDA-defined Snapshot Algorithm.
时间窗: Week 24
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 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
- PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State(0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8)
- PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State(0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8)
- PK Parameter:Ctau for BIC, FTC and TFV(0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8)
- PK Parameter: AUCtau for BIC, FTC, TAF, and TFV(0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8)
- PK Parameter: t1/2 of BIC, FTC, TAF, and TFV(0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8)
- The Change From Baseline in CD4+ Cell Count at Week 48(Baseline; Week 48)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase(First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase))
- Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase(First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase))
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48(Week 48)
- The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12(Baseline; Week 12)
- The Change From Baseline in CD4+ Cell Count at Week 24(Baseline; Week 24)
- The Change From Baseline in log10 HIV-1 RNA at Week 12(Baseline; Week 12)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12(Week 12)
- The Change From Baseline in log10 HIV-1 RNA at Week 24(Baseline; Week 24)
- The Change From Baseline in log10 HIV-1 RNA at Week 48(Baseline; Week 48)
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