jRCT2051230168进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 671
- 主要终点
- Proportion of participants with HIV-1 RNA 50 or more copies/mL at Week 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL.
- •At least one documented plasma HIV-1 RNA level measured between 6 and 12 months (+-2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL
- •Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- •Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR). 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(R))(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
结局指标
主要结局
Proportion of participants with HIV-1 RNA 50 or more copies/mL at Week 48
时间窗: Week 48
Proportion of participants with HIV-1 RNA 50 or more copies/mL as determined by the US FDA-defined snapshot algorithm
次要结局
- Proportion of participants with HIV-1 RNA < 50 copies/mL(Week 48, Week 96)
- Change from baseline in CD4 cell count(Week 48, Week 96)
- Proportion of participants experiencing treatment emergent AEs(Week 48, Week 96)
研究者
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