Phase IV, Open Label, Randomized, Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir Alafenamide/Emtricitabine/Darunavir/Cobicistat
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Proportion of patients who self-reported insomnia, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
研究概览
简要总结
A phase IV, multicentre, randomised, open-label, pilot clinical trial to evaluate the Reversibility of abacavir/lamivudine/dolutegravir ( ABC/3TC/DTG) CNS-Related Neurotoxicity After Switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c)
详细描述
The investigators estimate that 55 participants will need to be included per group, 110 patients in total, to demonstrate the benefit of switching ABC/3TC/DTG to TAF/FTC/DRV/c
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years of age diagnosed with HIV using conventional serology techniques.
- •Current antiretroviral therapy with ABC/3TC/DTG for at least 4 weeks.
- •HIV viral load < 50 copies/mL for at least 24 weeks prior to signing the consent form (confirmed by two assays at least 12 weeks apart with viremia < 50 copies/mL between both). If the patient has a recent routine blood test available (≤ 4 weeks) that includes determining HIV viral load, these results may be used for the screening visit. If this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion.
- •A positive screening test for sleep disorders detected using the sleep quality index (Pittsburgh ).
排除标准
- •Determination of at least one HIV viral load ≥ 50 copies/mL in the last 12 weeks.
- •Allergy, intolerance or existence of resistance mutations to any of the components of TAF/FTC/DRV/c.
- •History of active CNS infections.
- •Active psychosis, major depression with psychotic symptoms or autolytic ideation.
- •Dementia or mental retardation.
- •Drug use with a diagnosis of abuse or dependence according to DSM-5 criteria.
- •Illnesses that may interfere with the study procedures.
- •Inability to complete any of the study procedures.
- •Pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.
- •Patient with documented intolerance or hypersensitivity to the study medication, or who has a contraindication to use it, according to the technical data sheet
研究组 & 干预措施
Arm 1
Patients who postpone switching from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) four weeks
干预措施: ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c) (Drug)
Arm 2
Patients who switch from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) during the baseline visit
干预措施: Symtuza® (TAF/FTC/DRV/c) (Drug)
结局指标
主要结局
Proportion of patients who self-reported insomnia, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
时间窗: week 4
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the Pittsburgh sleep quality index (PSQI). The PSQI contains 19 questions in total. These questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates medium difficulty, within their respective area. The score of the seven areas is finally added for a global score, which ranges from 0 to 21 points. "0" indicates ease of sleep and "21" severe difficulty in all areas
次要结局
- Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c(Week 4 and 8 after switching to TAF/FTC/DRV/c)
- Percentage of virologic failure after switching antiretroviral therapy from ABC/3TC/DTG to TAF/FTC/DRV/c(Week 8 after switching to TAF/FTC/DRV/c)
- Proportion and severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c(Week 4 and 8 after switching to TAF/FTC/DRV/c)
- Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c(week 4)