HIV MedDRA version: 19.1 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Triumeq
Product Name: Triumeq
Pharmaceutical Form: Tablet
INN or Proposed INN: DOLUTEGRAVIR
CAS Number: 1051375-16-6
Sponsors
Fundación SEIMC-GESIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patient > 18 years of age diagnosed with HIV using normal serology techniques. •Current antiretroviral therapy with DTG/3TC/ABC. •HIV viral load =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; 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 ;Primary end point(s): The ACTG adverse effects scale, the Pittsburg sleep quality index and the hospital anxiety and depression scale.;Timepoint(s) of evaluation of this end point: Basal visit and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Contacts
Public ContactMaria Yllescas
Fundación SEIMC-GESIDA
Outcome results
None listed