Neurocognitive Function Improvement After Switching From Efavirenz to Rilpivirine in HIV-infected Adults: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change of neurocognitive function
研究概览
简要总结
People living with HIV in the era of antiretroviral therapy (ART) continue to suffer high rates of neurocognitive disorder. This is a randomized control trial aiming to evaluate improvement of neurocognitive function after switching efavirenz (EFV) to rilpivirine (RPV). EFV based regimen is currently the first line ART in Thailand. There are several reports suggested that HIV-infected patients who took EFV based regimen had poorer neurocognitive function compared to the comparator. RPV, another first line regimen, has been known to have less neuropsychiatric side effects. We hypothesized that switching EFV to RPV could improve neurocognitive function.
详细描述
People living with HIV (PLWH) in the era of antiretroviral therapy (ART) continue to suffer high rates of neurocognitive disorder. Previous report revealed that 36% of PLWH in Thailand had this condition. There are several reports suggested that HIV-infected patients who took efavirenz (EFV) based regimen had poorer neurocognitive function compared to the comparator. Rilpivirine (RPV), another first line regimen, has been known to have less neuropsychiatric side effects. We hypothesized that switching EFV to RPV could improve long term neurocognitive function.
PLWH (20 years and older) who received EFV-based regimen for at least 1 years at Chiang Mai University Hospital will be invited to this study. Neurocognitive function will be evaluated using 3 screening questions, International HIV Dementia Scale, Montreal Cognitive Assessment, and comprehensive neurocognitive battery test evaluating 6 different cognitive domains. The participants will be categorized in to 4 groups based on their neurocognitive test results; no evidence of neurocognitive deficit, asymptomatic neurocognitive impairment (ANI), mild neurocognitive disease (MND), and HIV associated dementia (HAD) using Frascati's criteria. The participants with ANI or MND and meet the eligibility criteria will be enrolled to this study. The participants will be randomized in to 2 arms; continuing EFV-based regimen or switching to RPV-based regimen. Neurocognitive function will be evaluated at 6 and 12 months.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HIV infection
- •Age 20 years old and above
- •On EFV-based regimen (EFV and 2 Nucleoside Reverse Transcriptase Inhibitors) for at least 1 year prior to enrollment
- •CD4 ≥ 200 cell/mm3 and viral load < 200 copies/mL within 12 months before enrollment
- •Able to be read and write in Thai language
- •Willing to sign informed consent and able to follow up
- •The neurocognitive battery test is compatible with asymptomatic neurocognitive impairment (ANI) or mild neurocognitive disorder (MND) using Frascati's criteria
排除标准
- •History of Traumatic Brain Injury, Developmental delay or intellectual deficit, or other neurological conditions have deleterious effects on neurocognitive test based on investigator opinion.
- •Active syphilis or on going to treatment with positive for syphilis serological marker (rapid plasma reagin; RPR) in 3 Months before entry study
- •Pregnancy
- •Renal failure (creatinine clearance < 30 mL/min)
- •Transaminitis in the past 3 months (≥5 UNL) Or Decompensated cirrhosis (child-pugh C)
- •Moderate depressive score; Patient Health Questionnaire-9 score ≥ 10)
- •Positive for any hepatitis B virus and hepatitis C virus serological marker in 3 Months before entry study
- •History of treatment failure or drug resistance to EFV and or RPV
- •Not suitable or contraindication for RPV (continue proton pump inhibitor drug)
研究组 & 干预措施
RPV-based
HIV-infected patients, who has been taking efavirenz-based regimen for at least 1 year and is diagnosed with asymptomatic neurocognitive impairment (ANI) or mild neurocognitive disease (MND) by neurocognitive battery tests, is randomized to switch antiretroviral therapy to rilpivirine (RPV)-based regimen.
RPV based regimen defines as rilpivirine 25 mg PO OD + 2 NRTIs.
干预措施: Rilpivirine 25 mg (Drug)
结局指标
主要结局
Change of neurocognitive function
时间窗: 12 months
Improvement is defined by changing neurocognitive status based on Frascati's criteria (using neurocognitive battery tests) 1) from Asymptomatic neurocognitive impairment (ANI) to normal OR 2) from Mild neurocognitive disorder; MND to ANI or normal.
次要结局
- Prevalence of neurocognitive disorder among HIV-infected patients who has received EFV for at least 1 year(3 months)
- Overall Global Deficit Score of all neurocognitive domains(12 months)
- Adverse reactions after switching from EFV to RPV(12 months)
研究者
Quanhathai Kaewpoowat
Principal Investigator
Chiang Mai University