Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence
概览
- 阶段
- 4 期
- 干预措施
- Tenofovir disoproxil/emtricitabine/rilpivirine
- 疾病 / 适应症
- HIV
- 发起方
- Sheba Medical Center
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- depression (questionaire)
- 状态
- 终止
- 最后更新
- 9年前
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.
研究者
Itsik Levi Dr
Head HIV/STDs unit
Sheba Medical Center
入排标准
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
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
atripla
Tab Atripla QD
干预措施: Tenofovir disoproxil/emtricitabine/efavirenz
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)