Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- depression (questionaire)
研究概览
简要总结
The aim of this prospective, open label study is to check for differences in neuropsychiatric and neurocognitive measurements among patients that will be switched from Atripla to Eviplera among 40 patients.
详细描述
40 patients on Atripla for at least 12 weeks with undetectable HIV-1 viral load will be randomly assigned to one of two groups in a ratio of 1:1: half of the patients will be switched to Eviplera and half will remain on Atripla. Neuropsychiatric symptoms will be evaluated using specific questionnaires (anxiety and depression scales, sleeping quality scale, etc) and neurocognitive functions will be assessed using standard tests (Trail A and B, memory tests, etc). Patient satisfaction will be assessed using a visual analog scale. Treatment efficacy will be evaluated by measuring the rate of patients with HIV vilral load under 50 copies/mL.
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
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
- •Ability to understand and sign a written informed consent form
- •Receiving Atripla continuously for >12 weeks preceding the screening visit
- •Plasma HIV-1 RNA levels (at least in two measurements) <50 copies/mL for >8 weeks prior to the screening visit and at the screening visit
- •Atripla or Truvada + Efavirenz was the first antiretroviral regimen and no HIV-1 RNA > 50 copies/mL measured at two consecutive time points after first achieving HIV RNA <50 copies/mL
- •Had a genotype prior to starting study drugs and no known resistance to any of the study drugs
- •Normal ECG
- •Hepatic transaminase (AST and ALT) <5 X upper limit of normal (ULN)
- •Total bilirubin <1.5 mg/dL
- •eGFR > 60 mL/min
- •Neutrophil count > 1000/mm3, platelets >50,000/mm
- •Haemoglobin > 8.5 g/dL
- •Age > 18
- •Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be nonheterosexually active, practice sexual abstinence, or have a vasectomized partner) from screening throughout the duration of the study period and for 60 days following the last dose of study drug.
排除标准
- •Subjects with known allergy to one of the study drugs
- •AIDS defining event diagnosed within 21 days prior to screening
- •Females who are pregnant or breast feeding
- •Acute hepatitis diagnosed within 21 days prior to screening
- •Subjects receiving drug treatment for HCV or subjects anticipated to receive treatment for HCV during the course of the study
- •Implanted defibrillator or pacemaker
- •Current alcohol or drug abuse judged by the investigator to potentially interfere with subject adherence
- •Participation in another interventional trial
- •Ongoing therapy or anticipated need to initiate drugs during the study that are contraindicated or not recommended for use with study drugs (Carbamazepine, Dexamethasone, Esomeprazole, Fosphenytoin, Lansoprazole, Omeprazole, Oxcarbazepine, Pantoprazole, Phenobarbital, Phenytoin, Piperaquine, Primnidone, Rabeprazole, Rifabutin, Rifampin, Rifapentine, St John's Wort
- •Any Severe Psychiatric disease that judged by the investigator to potentially interfere with subject adherence to protocol or to drugs or that may interfere with study procedures
研究组 & 干预措施
eviplera (complera)
Tab eviplera QD
干预措施: Tenofovir disoproxil/emtricitabine/rilpivirine (Drug)
atripla
Tab Atripla QD
干预措施: Tenofovir disoproxil/emtricitabine/efavirenz (Drug)
结局指标
主要结局
depression (questionaire)
时间窗: 12 month
PHQ which is a validated questionaire for depression
anxiety (questionaire)
时间窗: 12 month
STAI which is a validated questionaire for anxiety
sleeping quality (questionaire)
时间窗: 12 month
a validated questionaire
次要结局
- viral load (copies/mL)(24 month)
- Hopkins Verbal Learning Test - Revised (test result in numbers)(12 month)
- Satisfaction (scale)(12 month)
- clock drawing test (test result in numbers)(12 month)
- color trail test - 2 parts (test result in numbers)(12 month)
- grooved pegboard test (test result in numbers)(12 month)
- CD4 cell count (number of cells per mm3)(12 month)
研究者
Itsik Levi Dr
Head HIV/STDs unit
Sheba Medical Center