Status:
COMPLETED
Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Gilead Sciences
Conditions:
Neurocognitive Decline
HIV Associated Neurocognitive Disorder
Eligibility:
MALE
30-50 years
Phase:
PHASE4
Brief 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 Atripl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT02308332
Start Date
February 1 2015
End Date
June 1 2017
Last Update
October 27 2017
Active Locations (1)
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1
UMC Utrecht
Utrecht, Netherlands