NCT02308332

Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning

Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning, ESCAPE Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: Male
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effects of switching Atripla to Eviplera on neurocognition measured by neuropsychological testing and functional MRI

Detailed description

Efavirenz, an antiretroviral drug used for the treatment of human immunodeficiency virus 1 (HIV-1) infections, is known for its neurological and psychiatric adverse events. Efavirenz is part of Atripla®, a single tablet regimen (STR), currently the most prescribed antiretroviral drug in the Netherlands. Recently, a new STR has become available, Eviplera® containing a successor of Efavirenz, named Rilpivirin. It has been shown in the phase-3 ECHO and THRIVE studies that Atripla as well as Eviplera have excellent and comparable antiretroviral efficacy in naive HIV-infected patients. Furthermore, data from these studies have shown that Eviplera was associated with fewer neurological and psychiatric adverse events than Atripla over 48 weeks. However, this was only patient reported adverse events, not neuropsychological evaluation. Furthermore, they were treatment naïve for HIV. Moreover, there might be a bias in these kind of switch studies due to the fact that those patients who switch will mostly regard their new combination better than the old one. Contrary, data on the long term impact of Efavirenz on neuropsychological performance and symptoms are conflicting. Objective: This study aims to investigate the effect of switching from Atripla to Eviplera on neurocognitive performances (neurocognitive testing) and imaging (functional MRI scanning) in virologically suppressed HIV-infected patients.

Conditions

• Neurocognitive Decline
• HIV Associated Neurocognitive Disorder

Interventions

Type	Name	Description
DRUG	Eviplera	switch from Atripla to emtricitabine/rilpivirine/tenofovir (Eviplera)

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2014-12-04
• Last updated: 2017-10-27

Locations

1 site across 1 country: Netherlands