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Completed

NCT Number: NCT03835546

Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study

The ARBRE Study is an observational prospective trial aimed at investigating the impact of the therapy initiation with INTIs on brain outcomes according to the time of therapy initiation. Three study arms are considered: 1) Early treated HIV-1 infected patients (<3 months since estimated date of infection), 2) Regularly treated HIV-1 infected patients (>6 months since estimated date of infection), 3) Matched seronegative control group. Study assessments will be performed at baseline, 1 month and 12 months. Study assessments will comprise comprehensive evaluation of brain outcomes. They will include cognitive functioning, neuroimaging parameters, and functional outcomes.

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Key information

Conditions

HIV-1 Infection Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neurocognitive Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

Randomized patients will receive LA CAB+RPV administration in the hospital (standard of care) or out-of- hospital administration every 2 months (M2, M4, M6, M8,M10, M12). Medical visits, rutinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline, M1 (if patient has not previously receiving LA CAB+RPV), M6 and M12.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The study criteria for participation in the study will be the following:

Inclusion criteria

  • Age 18-65 years old
  • Voluntary participation.
  • Signed written consent.
  • Confirmed HIV-1 infection (for arms A and B).
  • Intention to initiate therapy with cART containing an INSTI. Specifically, the regimen included raltegravir, elvitegravir or dolutegravir.

Exclusion criteria

  • Prior diagnosis of opportunistic infection involving CNS.
  • Current diagnosis of psychiatric disorder.
  • Current or past diagnosis of neurologic disease.
  • Inability to develop any of the tasks required for the study.
  • Pregnancy.
  • History of suboptimal adherence (for arms A and B).

Treatment and study plan

Primary outcomes

  1. Change in Global Cognitive Functioning

    Time frame: From Baseline to Week 48

    The measure used will be NPZ-12 (NeuroPsychological Z-12). Minimum value: -5 Maximum value: +5. Mean: 0. Lower score will represent worse global cognitive functioning; higher score will represent better global cognitive functioning.

Secondary outcomes

  1. Change in Neuropsychiatric Symptoms

    Time frame: From Baseline to Week 48

    The measure used will be a checklist of symptoms involving the central nervous system. Minimum value: 0; Maximum value: 140. Lower score will represent better neuropsychiatric status; higher score will represent worse neuropsychiatric status.

  2. Change in Daily Living Functioning

    Time frame: From Baseline to Week 48

    Daily living functioning will be measured by a self-reported scale indicating daily living areas impaired. Minimum score: 0; Maximum score: 13. A lower score will represent better daily functioning; a higher score will represent worse daily functioning.

  3. Change in Depressive Symptoms

    Time frame: From baseline to week 48

    Depressive symptoms will be measured by a self-reported scale that will assess depressive symptoms. Minimum score: 0; Maximum score: 21. A lower score will represent better depressive status; a higher score will represent worse depressive status.

  4. Change in Anxiety Symptoms

    Time frame: From Baseline to Week 48

    Anxiety symptoms will be measured by a self-reported scale that will assess anxiety symptoms. Minimum score: 0; Maximum score: 21. A lower score will represent better anxiety status; a higher score will represent worse anxiety status.

  5. Change in Daily Perceived Stress

    Time frame: From baseline to week 48

    Perceived stress will be measured by a self-reported scale that will assess daily symptoms of perceived stress. Minimum score: 0; Maximum score: 40. A lower score will represent better perceived stress status; a higher score will represent worse perceived stress status.

  6. Change in Quality of Life

    Time frame: From Baseline to Week 48

    Quality of life will be measured by a self-reported scale that will assess global quality of life. Minimum score: 1; Maximum score: 4. A lower score will represent worse quality of life; a higher score will represent better quality of life.

  7. Change in Neuroimaging Markers

    Time frame: From Baseline to Week 48

    Neuroimaging markers will be assessed by 3T magnetic resonance imaging (MRI). The specific markers will be caudate nucleus, ventral striatum/nucleus accumbens, putamen, pallidum, thalamus, dorsomedial, dorsolateral, cingulate, ventromedial, medial orbitofrontal, and lateral orbitofrontal cortex. The outcome will be based on change in any of them.

Sponsors and collaborators

Lead sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Other

Collaborators

  • BCN Checkpoint
  • Consorci Sanitari de Terrassa
  • Germans Trias i Pujol Hospital
  • Institut d'Investigació Biomèdica de Bellvitge
  • Institut de Diagnostic per la Imatge
  • IrsiCaixa

Registry information

Official study title

Observational Prospective Trial to Investigate the Impact of Antiretroviral Therapy Initiation With Integrase Strand Transfer Inhibitors on Brain Outcomes:The ARBRE Study:Impact of AntiRetroviral Therapy With INSTI on BRain outcomEs (ARBRE) According to the Time of Therapy Initation

Acronym: ARBRE

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Feb 8, 2019
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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