The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 5
- 主要终点
- Proportion of participants with HIV-1 RNA
研究概览
简要总结
The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection
详细描述
HIV epidemic is still severe in China, the estimated number if PLWH in HIV is around 1.25 million all of China with an increasing trend of new cases. Late presenters with low CD4 T cells and/or with hight viral load should be paid more attention for better treatment and care. As a new combined antiretroviral regimen of integrase inhibitor, B/F/TAF was recently approved in US and European and also in China which needs more real world data in China. Non-inferiority or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China needs to be explored.
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
randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
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
- •1.Ability to understand and sign a written informed consent form 2.18 years old or older 3.Confirmed HIV-antibody positive through Western Blot testing without any previous ART 4.CD4 < 200/mm3, VL >1000 copies/ml 5.Estimated glomerular filtration rate (GFR) ≥ 50 mL/min (calculated by CKD-EPI) 6.Clinical status relatively stable 7.Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
排除标准
- •A new AIDS-defining condition diagnosed within the 30 days prior to screening
- •Participants experiencing severe organ lesion.
- •Positive serum pregnancy test or planned to be pregnant.
- •Females who are breastfeeding
- •With carcinoma
- •Concomitant medication of immunosuppression or chemoradiotherapy
- •Participation in any other interventional clinical trial
- •Screening stage find: Hb < 9g/dL, WBC < 3000/ul. neutrophilic granulocyte< 1500/ul, PLT< 75000/ul. Scr > 1.5 ULN,Hepatic transaminases (AST and ALT) and ALP > 3 × ULN,total bilirubin ≤ 2 x ULN.
- •Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
研究组 & 干预措施
B/F/TAF
50mg/600mg/300mg
干预措施: B/F/TAF (Drug)
TDF/3TC/EFV
300mg/300mg/400mg
干预措施: TDF/3TC/EFV (Drug)
结局指标
主要结局
Proportion of participants with HIV-1 RNA
时间窗: base line,Weeks 12,24 and 48
Proportion of participants with HIV-1 RNA
The Change in CD4 T cell count from baseline
时间窗: base line,Weeks 12, 24 and 48
The Change in CD4 T cell count from baseline
次要结局
未报告次要终点
研究者
Wei LYU
Chief Physician
Peking Union Medical College Hospital