A Pilot Randomized Controlled Trial of Switch to Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus Continue TDF/FTC/Efavirenz (EFV) Treatment Among Virologically Suppressed, HIV-1 Infected Subjects With Mild or Asymptomatic EFV-related Neurocognitive or Neuropsychological Side Effects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- Neurocognitive side effects
研究概览
简要总结
Despite long-term use in clinical practice, chronic treatment with efavirenz (EFV) has been associated with persistent central nervous system symptoms or mild or even asymptomatic neurocognitive impairment. Whether switching to rilpivirine (RPV) containing regimen is beneficial among patients who experience mild or asymptomatic neurocognitive/neuropsychiatric adverse events during EFV has not been explored yet.
The proposed pilot study will examine whether switching from single tablet regimen TDF/FTC/EFV to single tablet regimen TDF/FTC/RPV is associated with neurocognitive/neuropsychiatric improvement among HIV-infected patients with mild/asymptomatic neurocognitive impairment or neuropsychiatric symptoms during EFV-containing antiretroviral treatment.
Patients under stable treatment with TDF/FTC/EFV, confirmed HIV-1 RNA viral load < 50 copies/mL and altered scores in depression, quality of sleep or anxiety tests and/or alteration in 1 or more domains as assessed by neuropsychological assessment, will be randomized to immediate or deferred (24 weeks) switch to TDF/FTC/RPV. Neurocognitive and neuropsychiatric tests will be repeated after 12, 24 and 48 weeks of follow-up and variations will be compared between groups.
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 old and ability to sign informed consent
- •Continuative treatment with TDF/FTC/EFV for ≥180 days
- •HIV-1 RNA viral load < 50 copies/mL in two consecutive determinations (including screening)
- •No history of treatment failure and/or evidence of any mutations associated with resistance to NRTI or NNRTI
- •No contraindication to treatment with study drugs
- •Any one of the following conditions:
- •(i) Altered scores in depression, quality of sleep or anxiety tests (ii) Alteration in 1 or more domains as assessed by neuropsychological assessment
排除标准
- •Ongoing treatment or predictable need of treatment with proton pump inhibitors
- •New AIDS defining condition diagnosed within the 21 days prior to screening
- •Previous diagnosis of AIDS dementia complex
- •Current alcohol or substance dependence
- •Major psychiatric disorders
- •Decompensated cirrhosis
- •Plasma creatinine >1.2 mg/dl or estimated glomerular filtration rate <60 ml/min (MDRD formula)
- •AST, ALT or plasma bilirubin >3 times upper limit of normal
- •Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing/food requirements
研究组 & 干预措施
Immediate Switch
Immediate switch to TDF/FTC/RPV
干预措施: Immediate switch to TDF/FTC/RPV (Drug)
Deferred Switch
Switch to TDF/FTC/RPV after 24 weeks
干预措施: Switch to TDF/FTC/RPV after 24 weeks (Drug)
结局指标
主要结局
Neurocognitive side effects
时间窗: 24 weeks
- Proportion of patients with improvement in neurocognitive performances in either one of the 7 domains investigated, evaluated either as a binary (Abnormal/Normal) or on a continuous scale (deficit score)
Composite neuropsychiatric/neurocognitive
时间窗: 24 weeks
Proportion of patients with improvement in either one of the previous binary end-point (composite end-point)
Neuropsychiatric side effects
时间窗: 24 weeks
Proportion of patients with improvement in depression, anxiety or quality of sleep scores, evaluated either as a binary (Yes/No) or on a continuous scale
次要结局
- Cognitive failure(24 weeks)
- Symptoms(24 weeks)
- Quality of Life(24 weeks)
- Viral failure(12 weeks)
- Virological efficacy(24 weeks)
- Viral suppression(12 weeks)
- Safety & Tolerability(24 weeks)
研究者
Giuseppe Lapadula
M.D. Ph.D
Azienda Ospedaliera San Gerardo di Monza