Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning

NCT02308332 | Completed Phase 4

• 1 other identifier: ABR50959
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurocognitive Decline; HIV Associated Neurocognitive Disorder

Outcome Measures

Primary Outcomes (1)

• To evaluate the neurocognitive performance as measured by neuropsychological test composite score after 12 weeks in stable HIV-infected patients switched from Atripla to Eviplera compared to a control group of patients on Atripla.

  Patients will undergo a neuropsychological test battery where multiple standardized test will be undertaken to assess 7 different domains; Verbal Fluency, Executive Functioning, Speed of Information Processing, Learning, Memory, Attention/Working Memory, Motor skills. Raw scores can be calculated per domain and as a composite score. Differences in mean changes in composite score between baseline and end of study will be assessed with a paired T-test. A p-value \<0.05 will be considered statistically significant. Within-arm changes will be assessed using Wilcoxon signed rank tests, and between-group comparisons will be evaluated with Wilcoxon rank sum tests. Multivariate analyses will be performed to analyse differences in the primary endpoints between the study groups.

  12 weeks

Secondary Outcomes (6)

• to assess the correlation between neurocognitive improvement (neuropsychological evaluation) and functional imaging (fMRI) after switching Atripla to Eviplera

  12 weeks

• to evaluate correlation between neurocognitive performance and health related quality of life measured by SF-36 total score after switching from Atripla to Eviplera.

  12 weeks

• to assess the emotional functioning measured by HADS total score after switching Atripla to Eviplera by using a paired T-test to calculate differences in mean changes between baseline and end of study

  12 weeks

• to assess USER-P (total scores) after switching Atripla to Eviplera

  12 weeks

• to assess drug levels of Efavirenz (as a component of Atripla) and Rilpivirin (as a component of Eviplera) in relation to changes in neurocognitive performance and fMRI in both patient groups.

  12 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

patients switching from Atripla to Eviplera

Drug: Eviplera

Control

NO INTERVENTION

patients remaining on Atripla

Interventions

Eviplera DRUG

switch from Atripla to emtricitabine/rilpivirine/tenofovir (Eviplera)

Also known as: emtricitabine/rilpivirine/tenofovir

Intervention

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• Gilead Sciences: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

• Oomen PGA, Hakkers CS, Arends JE, van der Berk GEL, Pas P, Hoepelman AIM, van Welzen BJ, du Plessis S. Underlying Neural Mechanisms of Cognitive Improvement in Fronto-striatal Response Inhibition in People Living with HIV Switching Off Efavirenz: A Randomized Controlled BOLD fMRI Trial. Infect Dis Ther. 2024 May;13(5):1067-1082. doi: 10.1007/s40121-024-00966-7. Epub 2024 Apr 20.

  PMID: 38642238 DERIVED

MeSH Terms

Interventions

Emtricitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Joop Arends, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious Diseases Physician

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 4, 2014
• Study Start: February 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

NL (1)