An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 129
- 试验地点
- 19
- 主要终点
- Phase 2: Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm.
研究概览
简要总结
Phase 2: To evaluate the efficacy of switching to a bictegravir (BIC) + lenacapavir (LEN) regimen versus continuing on stable baseline regimen (SBR) in virologically suppressed people with HIV-1 as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 Phase 3: To evaluate the efficacy of switching to BIC/LEN fixed-dose combination (FDC) tablet regimen versus continuing on a SBR in virologically suppressed people with HIV-1 as determined by the proportion of participants with HIV--1 RNA ≥ 50 copies/mL at Week 48.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Documented plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels must be < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months prior to the screening visit (Phase 2 only).
- •If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL (Phase 3 only).
- •Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to the components of existing single-tablet regimens, and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows: A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or A regimen containing parenteral agent(s) (excluding a complete long acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
- •No documented or suspected resistance to bictegravir (BIC).
- •Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft- Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.
排除标准
- •Prior use of, or exposure to, lenacapavir (LEN)
- •Active tuberculosis infection
- •Chronic hepatitis B virus (HBV) infection
研究组 & 干预措施
-
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Phase 2: Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm.
Phase 2: Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm.
Phase 3: Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm.
Phase 3: Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm.
次要结局
- Phase 2: Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 24 as determined by the US FDA-defined snapshot algorithm.
- Change from baseline in CD4 cell count at Week 24
- Proportion of participants experiencing treatment-emergent adverse events (AEs) through Week 24
- PK parameters Cmax, AUCtau, and Ctau (as applicable) of BIC and LEN
- Phase 3: Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as determined by the US FDA–defined snapshot algorithm.
- Change from baseline in CD4 cell count at Weeks 48.
- Proportion of participants experiencing treatment-emergent AEs through Week 48.
- Proportion of participants from Treatment Group 1 with HIV-1 RNA ≥ 50 copies/mL at Week 96 as determined by the US FDA-defined snapshot algorithm
- Proportion of participants from Treatment Group 1 experiencing treatment-emergent AEs through Week 96
- Change from baseline in CD4 cell count at Week 96 for participants from Treatment Group 1
研究者
EU Clinical Trials Support
Scientific
Gilead Sciences Inc.