A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of 2-drug Injectable Regimens of VH4011499 Plus Cabotegravir in Treatment Naïve Viremic Adult Participants With HIV-1 (CINERGY)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
研究概览
简要总结
The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI). This study will explore 4 different regimens of VH4011499 when paired with cabotegravir (CAB) as an initial two-drug regimen.
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
- None
盲法说明
This is an open-label study.
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
- •Participant must be at least 18 years of age (or older, if required for adults by local regulations).
- •Screening CD4+ T-cell count ≥ 200 cells/µL.
- •Documented HIV-1 infection and screening plasma HIV-1 RNA ≥
- •1 000 and ≤ 100 000 copies/mL.
- •Treatment-naïve. Prior use of oral pre-exposure prophylaxis (PrEP) or oral post-exposure prophylaxis (PEP) that is not INSTI or CAI based is permitted.
- •Body weight ≥ 50.0 kg (110 lbs) for participants assigned male at birth and ≥ 45.0 kg (99 lbs) for participants assigned female at birth.
- •Agrees to adequate birth control if a participant of childbearing potential
排除标准
- •Participants with acute HIV-1 infection
- •Prior exposure to any HIV-1 capsid inhibitor or any HIV-1 INSTI for any reason is prohibited.
- •Participants with known or suspected presence of major virologic resistance mutations to study drugs
- •Unstable liver disease
- •Participants with HCV co-infection
- •Participant has evidence of chronic active HBV infection
- •Clinically significant cardiovascular disease
研究组 & 干预措施
VH4011499 dose Group 1 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 1, which differs from all other arms) and cabotegravir (CAB).
干预措施: VH4011499 (Drug)
VH4011499 dose Group 4 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 4, which differs from all other arms) and CAB.
干预措施: VH4011499 (Drug)
VH4011499 dose Group 4 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 4, which differs from all other arms) and CAB.
干预措施: CAB (Drug)
DTG/3TC
Active control arm receiving daily oral standard of care antiretroviral therapy (dolutegravir 50 mg / lamivudine 300 mg single-tablet regimen).
干预措施: DTG/3TC (Drug)
VH4011499 dose Group 2 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 2, which differs from all other arms) and CAB.
干预措施: VH4011499 (Drug)
VH4011499 dose Group 2 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 2, which differs from all other arms) and CAB.
干预措施: CAB (Drug)
VH4011499 dose Group 1 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 1, which differs from all other arms) and cabotegravir (CAB).
干预措施: CAB (Drug)
VH4011499 dose Group 3 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 3, which differs from all other arms) and CAB.
干预措施: VH4011499 (Drug)
VH4011499 dose Group 3 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 3, which differs from all other arms) and CAB.
干预措施: CAB (Drug)
结局指标
主要结局
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
时间窗: At Month 7
次要结局
- Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm(At Month 13 and Month 25)
- Number of participants with plasma HIV-1 RNA <50 copies/mL as per observed data(At Month 7, Month 13 and Month 25)
- Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count(At Month 7, Month 13 and Month 25)
- Number of participants with injection site reaction adverse events of special interest (ISR AESIs) by grade(Through Month 7, Month 13 and Month 25)
- Duration of ISR AESIs by grade(Through Month 7, Month 13 and Month 25)
- Number of participants with serious adverse events (SAEs) by grade(Through Month 7, Month 13 and Month 25)
- Number of participants with adverse events (AEs) leading to study treatment discontinuation, by grade(Through Month 7, Month 13 and Month 25)
- Plasma concentrations of VH4011499(Through Months 7, 13 and 25)