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

INTERVENTION:

Trade Name: Triumeq Product Name: Triumeq Pharmaceutical Form: Tablet INN or Proposed

INN:

DOLUTEGRAVIR CAS Number: 1051375‐16‐6 Other descriptive name: DOLUTEGRAVIR SODIUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed

INN:

LAMIVUDINE CAS Number: 134678‐17‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ INN or Proposed

INN:

ABACAVIR CAS Number: 188062‐50‐2 Other descriptive name: ABACAVIR SULFATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Trade Name: Genvoya Product Name: Genvoya Pharmaceutical Form: Tablet INN or Proposed

INN:

ELVITEGRAVIR CAS Number: 697761‐98‐1 Other descriptive name: ELVITEGRAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ INN or Proposed

INN:

COBICISTAT CAS Number: 1004316‐88‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ INN or Proposed

INN:

EMTRICITABINE CAS Number: 143491‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed

INN:

TENOFOVIR CAS Number: 379270‐37‐8 Other descriptive name: TENOFOVIR ALAFENAMIDE FUMARATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐

CONDITION:

HIV ; MedDRA version: 19.1 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Virus Diseases [C02]

PRIMARY OUTCOME:

Main Objective: To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy Primary end point(s): The ACTG adverse effects scale, the Pittsburg sleep quality index and the hospital anxiety and depression scale. Secondary Objective: ‐ To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF; ‐To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF; ‐ To evaluate the percentages of virologic failure after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF Timepoint(s) of evaluation of this end point: Basal visit and week 4

SECONDARY OUTCOME:

Secondary end point(s): ‐The ACTG adverse effects scale, the Pittsburg sleep quality index and the hospital anxiety and depression scale.; ‐ Volumes of the different structures of the brain ; the Change in levels of neuronal integrity, the change in the level of white matter integrity, and change in levels of brain inflammation.; ‐ Viral load Timepoint(s) of evaluation of this end point: ‐Weeks 4, 12 and 24 after the change.

INCLUSION CRITERIA:

•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