Pharmacodynamics of Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients in a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Viral suppression
研究概览
简要总结
Evaluating the efficacy, pharmacodynamics, and safety of Efavirenz 400mg in treatment-naïve Chinese HIV-infected patients.
详细描述
Treatment-naive HIV-infected patients are designed to enroll and receive efavirenz 400mg combined with tenofovir (TDF) and lamivudine (3TC) as initial antiretroviral regimens, and monitoring for 48 weeks, to evaluate efavirenz concentration, T-cell subsets, HIV RNA load, and neuropsychiatric tests with Hamilton depression scale (HAMD) and Pittsburgh sleep quality index (PSQI) at baseline, 4, 12, 24, 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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) HIV treatment-naïve, (2) age between 18 years or older, (3) be willing to complete the HAMD and PSQI scale and follow-up regularly, (5) not participating in other studies.
排除标准
- •(1) acute HIV-1-infected patients, (2) an AIDS-defining illness such as pneumocystis pneumonia, tuberculosis within 2 weeks of entry, (3) transaminase and alkaline phosphatase levels beyond three times the upper limit of the normal range, bilirubin level more than 2.5 times the upper limit of the normal range, and serum creatinine level excess 1.5 times the upper limit of the normal range, (4) pregnancy or breast feeding
研究组 & 干预措施
Efavirenz 400mg+TDF+3TC
Combined antiretroviral therapy(cART) consisting of three regimens such as efavirenz, tenofovir and lamivudine is an effective measure for the treatment of HIV-1 infection.Efavirenz 600mg daily was approved by the US Food and Drug Administration in 1998. In this single-arm research, patients were treated with a reduced 400mg dose of efavirenz combined with tenofovir 300mg and lamivudine 300mg once a day. This treatment had to be maintained indefinitely due to the existence of HIV reservoir.
干预措施: Efavirenz 400mg (Drug)
结局指标
主要结局
Viral suppression
时间窗: 48 weeks
The proportion of patients with viral load less than 50 copies/mL
次要结局
- Drug concentration(48 weeks)
- Neuropsychiatric adverse events(48 weeks)
研究者
LI Taisheng
Director in department of Infectious Diseases
Peking Union Medical College Hospital