HIV MedDRA version: 20.0 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Symtuza
Product Name: Symtuza
Pharmaceutical Form: Tablet
INN or Proposed INN: TENOFOVIR ALAFENAMIDA
CAS Number: 379270-37-8
Other descriptive name: TENOFOVIR ALAFENAMIDE
Concentration uni
Sponsors
Fundación SEIMC-GESIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Patient = 18 years of age diagnosed with HIV using conventional serology techniques. * Current antiretroviral therapy with ABC/3TC/DTG for at least 4 weeks. * 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 TAF/FTC/DRV/c. * 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. * 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: Compare at week 4 changes in the proportion of patients who self-reported insomnia, between HIV-suppressed patients who continue abacavir/lamivudine/dolutegravir (ABC/3TC/DTG)and those who switched to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c);Secondary Objective: - Compare at week 4 changes in the proportion and severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue abacavir/lamivudine/dolutegravir (ABC/3TC/DTG) and those who switched to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c) - To evaluate changes in the proportion and severity of neuropsychiatric symptoms potentially associated with the use of abacavir/lamivudine/dolutegravir (ABC/3TC/DTG) after switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c) - To evaluate the percentages of virologic failure after switching antiretroviral therapy from abacavir/lamivudine/dolutegravir (ABC/3TC/DTG) to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c).;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 - Viral load;Timepoint(s) of evaluation of this end point: Weeks 4 and 8 after the change | — |
Countries
Spain
Contacts
Public ContactMarta de Miguel
Fundación SEIMC-GESIDA
Outcome results
None listed