Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Symptoms and neurological side effects of study drugs
研究概览
简要总结
Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams, dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of treatment, with subsequent attenuation but may not completely resolve even years after efavirenz initiation.
The investigators plan a four week, randomized, placebo-controlled, double-blind study. In group 1, efavirenz will be replaced with efavirenz placebo plus raltegravir, in group 2, efavirenz would be continued, and raltegravir placebo given in addition. After two weeks, patients in group 1 would switch to the regimen of group 2, and vice versa.
The primary endpoint of the trial will be patient preference. Sleep quality, daytime sleepiness, and anxiety will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Adult patients > 18 years
- •Signing the study consent form and agree to change ART regimen
- •Stable HAART including EFV since at least 3 months
- •HIV-RNA below 50 copies for at least 3 months
排除标准
- •No major psychiatric disease (psychosis, severe depression) diagnosed before the initiation of EFV
- •Mentally incompetent patients
- •Pregnancy or lactation Women of childbearing potential must use one or two reliable contraceptive methods during the trial, from day 1 to the end of week
- •Acceptable methods include the birth control pill, IUD, condoms with spermicides. Non-acceptable methods include (non-exhaustive list): Withdrawal, calendar (Onigo method), or spermicides alone.
- •Concomitant renal or hepatic disease:
- •Creatinine above 150 micromol/L
- •Transaminases above 5 times upper normal limit
- •Prothrombin (Quick) value below 50%
研究组 & 干预措施
Raltegravir first
Patients treated with Raltegravir for first 2 weeks
干预措施: Raltegravir for the first 2 weeks (Drug)
Raltegravir first
Patients treated with Raltegravir for first 2 weeks
干预措施: Efavirenz for the last 2 weeks (Drug)
Efavirenz first
Patients treated with Efavirenz for first 2 weeks
干预措施: Efavirenz for the first 2 weeks (Drug)
Efavirenz first
Patients treated with Efavirenz for first 2 weeks
干预措施: Raltegravir for the last 2 weeks (Drug)
结局指标
主要结局
Symptoms and neurological side effects of study drugs
时间窗: baseline, week 2 and week 4
次要结局
- Levels of daytime sleepiness(baseline, week 2 and week 4)
- Sleep Quality(baseline, week 2 and week 4)
- Patient preference(4 weeks)
- Symptoms of depression, anxiety and stress will be assessed(baseline, week 2 and week 4)