A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c)

  • STATUS
    Not Recruiting
  • participants needed
    110
  • sponsor
    Fundacion SEIMC-GESIDA
Updated on 13 June 2021
Investigator
Alfonso Angel-Moreno Maroto
Primary Contact
Hospital Puerta de Hierro (4.4 mi away) Contact
+5 other location
antiretroviral agents
antiretroviral therapy
tenofovir
emtricitabine
cobicistat
hiv viral load
darunavir
dolutegravir
lamivudine
abacavir
viremia
abacavir/lamivudine

Summary

A phase IV, multicentre, randomised, open-label, pilot clinical trial to evaluate the Reversibility of abacavir/lamivudine/dolutegravir ( ABC/3TC/DTG) CNS-Related Neurotoxicity After Switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c)

Description

The investigators estimate that 55 participants will need to be included per group, 110 patients in total, to demonstrate the benefit of switching ABC/3TC/DTG to TAF/FTC/DRV/c

Details
Condition HIV infection, Immunodeficiency, Primary Immunodeficiency Disorders, HIV Infections
Treatment Symtuza® (TAF/FTC/DRV/c), ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)
Clinical Study IdentifierNCT03685500
SponsorFundacion SEIMC-GESIDA
Last Modified on13 June 2021

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