Randomized, Double-Blinded Clinical Trial to Evaluate the Incidence and Severity of Neuropsychiatric Side Effects and Antiviral Efficacy of Efavirenz Given as a Stepped Dosage Over 2 Weeks Versus the Usual Dosage in HIV-Infected Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 10
- 主要终点
- incidence and severity of neuropsychiatric side effects
研究概览
简要总结
Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.
Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the usual dosage.
Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm B: 600 mg qd from the first day). All patients received additional treatment with 2 NRTIs.
The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type scale specifically designed. Efficacy was assessed by percent of virological failures.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age older than 18 years
- •HIV-1 infection
- •Women of child-bearing age: negative pregnancy test
- •Ability to understand and sign a written consent form
排除标准
- •Pregnancy..
- •Illegal drug or methadone use.
- •Major psychiatric disease antecedents or starting new psychotropic agents in the last 4 weeks
- •Concomitant treatment with rifamycins, protease inhibitors or drugs which interfere the pharmacokinetic of efavirenz.
- •Hepatic insufficiency
研究组 & 干预措施
B
干预措施: Efavirenz (Drug)
A
干预措施: Efavirenz (Drug)
结局指标
主要结局
incidence and severity of neuropsychiatric side effects
时间窗: 4 weeks
次要结局
- Virological efficacy(24 weeks)