A phase IV open- label, randomized and pilot clinical trial, designed to evaluate the potential neurotoxicity of dolutegravir/lamivudine/abacavir in neurosymptomatic HIV patients and their reversibility after switching to elvitegravir/cobicistat/emtricitabina/tenofovir alafenamide - DREAM

Fundación SEIMC-GESIDA0 个研究点目标入组 64 人开始时间: 2017年4月21日最近更新: 2019年6月30日

试验速览

暂无简介。

•Patient > 18 years of age diagnosed with HIV using normal serology techniques.
•Current antiretroviral therapy with DTG/3TC/ABC.
•HIV viral load < 50 copies/mL for at least 12 weeks prior to signing the consent form [(]confirmed by two assays at least 12 weeks apart with viremia < 50 copies/mL between both
•Appearance or worsening of the following symptoms compared to when DTG/3TC/ABC was started:
•- Symptoms of anxiety or depression
•- Insomnia or other sleep disturbances
•- Headache
•- Cognitive complaints (attention, concentration or memory)
•- Alterations in behaviour (irritability, aggressiveness or agitation)
•- Dizziness of neurological or neurologically-mediated origin
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 64
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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 ELV/COBI/FTC/TAF
•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
•Claustrophobia
•Presence of magnetisable devices in the body
•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.

发起方

Fundación SEIMC-GESIDA