Quality of Life Clinical Trial
Official title:
A Pilot Randomized Controlled Trial of Switch to Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus Continue TDF/FTC/Efavirenz (EFV) Treatment Among Virologically Suppressed, HIV-1 Infected Subjects With Mild or Asymptomatic EFV-related Neurocognitive or Neuropsychological Side Effects
Despite long-term use in clinical practice, chronic treatment with efavirenz (EFV) has been
associated with persistent central nervous system symptoms or mild or even asymptomatic
neurocognitive impairment. Whether switching to rilpivirine (RPV) containing regimen is
beneficial among patients who experience mild or asymptomatic neurocognitive/neuropsychiatric
adverse events during EFV has not been explored yet.
The proposed pilot study will examine whether switching from single tablet regimen
TDF/FTC/EFV to single tablet regimen TDF/FTC/RPV is associated with
neurocognitive/neuropsychiatric improvement among HIV-infected patients with
mild/asymptomatic neurocognitive impairment or neuropsychiatric symptoms during
EFV-containing antiretroviral treatment.
Patients under stable treatment with TDF/FTC/EFV, confirmed HIV-1 RNA viral load < 50
copies/mL and altered scores in depression, quality of sleep or anxiety tests and/or
alteration in 1 or more domains as assessed by neuropsychological assessment, will be
randomized to immediate or deferred (24 weeks) switch to TDF/FTC/RPV. Neurocognitive and
neuropsychiatric tests will be repeated after 12, 24 and 48 weeks of follow-up and variations
will be compared between groups.
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