Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning (ESCAPE)

UMC Utrecht

Status and phase

Completed

Phase 4

Conditions

Neurocognitive Decline

HIV Associated Neurocognitive Disorder

Treatments

Drug: Eviplera

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02308332

ABR50959

Details and patient eligibility

About

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

Full 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.

Enrollment

58 patients

Sex

Male

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male, between 30 and 50 years
HIV-1 RNA < 50 copies/mL on screening visit
on Atripla continuously for ≥6 months preceding the screening visit
Have a HIV genotype prior to starting cART with Atripla with no known resistance to any of the study agents at any time in the past including, but not limited to RT mutations K65R, K101E/P, E138G/K/Q/R, Y181C/I/V, M184V/I and H221Y
Negative TPHA or VDRL < 12 months prior to the screening visit
no signs of an acute or chronic hepatitis C infection within the past 12 months before screening as defined in the Dutch guideline (Arends et al. Neth J Med 2011)
No subjective neurocognitive complaints in the preceding 12 months
willingness to take Eviplera together with food according to the manufacturer's prescriptions.
Estimated glomerular filtration rate ≥50 mL/min (Cockcroft-Gault formula) on last routine measurement during outpatient clinic
able to understand and comply to study procedures and to provide written informed consent

Exclusion criteria

Non-native Dutch speakers
Proven major depression through psychiatric consultation within the past year or on anti-depressant drugs (SSRI or TCA)
Active or known from medical history past CNS opportunistic infections
History of proven neurologic disease (e.g. multiple sclerosis, brain tumor, cerebrovascular event, etc)
Active psychiatric disorders classified according to the DMS V criteria
History or evidence of alcohol or drug abuse defined according to DSM V criteria
TSH within normal reference values on last routine measurement during outpatient clinic
Contraindications for undergoing an MRI; a pacemaker or metallic devices/foreign bodies in situ, proven claustrophobia.