Effect of Dolutegravir + Tenofovir Disoproxil Fumarato/Emtricitabina Compared With Darunavir/Cobicistat + Tenofovir Disoproxil/Fumarato /Emtricitabina on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults With HIV-1 Infection
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Change in neuropsychiatric scales for Insomnia
研究概览
简要总结
This clinical trial aimed at evaluating changes in neuropsychiatric scales for depression, anxiety, insomnia, and sleep quality in people living with HIV (PLHIV) who initiate antiretroviral therapy (ART) with a regimen of Dolutegravir (DTG) or Darunavir/Cobicistat (DRV/c), both combined with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).
详细描述
This clinical trial aims to evaluate changes in neuropsychiatric scale (NPS) scores among Mexican men living with HIV who present baseline NPS symptoms and are naïve to antiretroviral therapy (ART). Participants will initiate either a Dolutegravir (DTG)-based regimen or a Darunavir/Cobicistat (DRV/c)-based regimen, both combined with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). All patients will undergo a psychiatric evaluation prior to ART initiation. Treatment discontinuation will be considered for participants experiencing an exacerbation of NPS symptoms associated with grade ≥2 adverse events. NPS scores will be assessed and compared at weeks 4 and 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Patients living with HIV not experienced to ART
- •Age ≥ 18 years.
- •eGFR >60 mL/min
- •Beneficiaries of the Mexican Social Security Institute treated at the "La Raza" National Medical Center
- •Patients with a baseline ISI scale score: ≥8-14 points
- •Patients with a baseline PHQ-9 scale score: 5-9 points
- •Patients with a baseline HADS-A scale score: 8-10 points
- •Patients with a baseline HADS-D scale score: 8-10 points
- •Patients with a baseline Pittsburgh scale score: 5-7 points.
排除标准
- •Patients with use of antidepressants/anxiolytics prior to starting ART
- •Any Contraindication for the use of second generation INSTI or IP ART regimen
- •Coinfection with Hepatitis C Virus
- •Known resistance mutations to any of the components of both treatment regimens.
研究组 & 干预措施
DTG + TDF/FTC
Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine
干预措施: Dolutegravir (DTG) (Drug)
DRV/c + TDF/FTC
Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine
干预措施: Darunavir/Cobicistat (FDC) (Drug)
结局指标
主要结局
Change in neuropsychiatric scales for Insomnia
时间窗: 12 weeks
Change in scales evaluating the severity of neuropsychiatric effects (Insomnia Severity Index (ISI) in patients living with HIV who are naïve to antiretroviral therapy who initiate therapy with Dolutegravir + Tenofovir Disoproxil Fumarate/Emtricitabine compared to Darunavir/cobicistat + Tenofovir Disoproxil Fumarate/Emtricitabine at 12 weeks of treatment.
次要结局
- Discontinuation of ART due to Neuropsychiatric adverde effects(12 weeks)
- Risk factor associated with increase in neuropsychiatric scales(12 weeks)
研究者
José Antonio Mata Marín
Principal Investigator
Instituto Mexicano del Seguro Social