The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- neuropsychiatric symptoms severity in 3 months
研究概览
简要总结
Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir.
详细描述
Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir. The main outcome measure will be a global severity index (GSI) of neuropsychiatric symptoms arising from 10 symptom domains, including somatization, obsessive-compulsiveness, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism. The secondary outcomes are to compare, between arms and during follow up, neuropsychiatric symptoms severity, neurocognitive performance, changes in self-reported symptoms, adherence and HR-QoL, correlation between symptoms (neuropsychiatric and other), drug exposure and HR-QoL, proportion of adverse events, proportion of virological failures and antiretrovirals resistance at virological failure.
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
- •Age >18 years
- •HIV-1 infection
- •HIV RNA <50 copies/mL >12 months (including patients with 1 blip 50-200 cp/mL before screening, not confirmed)
- •On treatment with dolutegravir/abacavir/lamivudine >6 months
排除标准
- •Previous AIDS events
- •Pregnancy or pregnancy plan
- •Decompensated cirrhosis (B or C CPT status)
- •Intake of alcohol, substances, other drugs that may affect neurocognitive performances
- •Necessity to receive drugs that may require dosing adjustment of dolutegravir or bictegravir
- •Certified diagnosis of major depression, psychosis, history of suicidal attempts
- •Treatment with antidepressants or antipsychotic drugs
- •History of virological failure with INSTIs
- •Lack of knowledge of italian language
- •Impossibility to obtain informed written consent
- •HBsAg positivity
- •Estimated glomerular filtration rate by CK-EPI <50 mL/min per 1.73 m2
研究组 & 干预措施
Bictegravir/emtricitabine/tenofovir alafenamide
Patients with suppressed viral load switching from dolutegravur/lamivudina/abacavir (50/300/600 mg) 1 tablet OD to bictegravir/emtricitabine/tenofovir alafenamide (50/200/25 mg) 1 tablet OD
干预措施: Bictegravir/emtricitabine/tenofovir alafenamide (Drug)
Dolutegravir/lamivudine/abacavir
Patients with suppressed viral load continuing dolutegravir/lamivudine/abacavir (50/300/600 mg) 1 tablet OD
干预措施: Dolutegravir/lamivudine/abacavir (Drug)
结局指标
主要结局
neuropsychiatric symptoms severity in 3 months
时间窗: 3 months
change in neuropsychiatric symptoms severity, using the Symptom Checklist-90-R, 3 months after switching to bictegravir or continuing dolutegravir (on treatment analysis).
次要结局
- neurocognitive performance(12 months)
- self-reported symptoms (21 items, 0-5 points for each), adherence (0-100%) and HR-QoL (9 items, 0-5 points for each)(12 months)
- Mini International Neuropsychiatric Interview Plus subscale for suicide risk(12 months)
- neurocognitive impairment and neuropsychiatric symptoms(12 months)
- virological failures(12 months)
- neuropsychiatric symptoms severity in 3 and 12 months(12 months)
- Treatment Satisfaction(12 months)
- drug exposure(12 months)
- adverse events(12 months)
研究者
Barbara Rossetti
Principal Investigator
Azienda Ospedaliera Universitaria Senese