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

Cognitive Impairment Clinical Trial

— ARBRE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835546
• Other study ID #: FLS-ANT-2015-01
• Status: Completed
• Start date: October 26, 2015
• Est. completion date: June 29, 2018

Study information

• Verified date: November 2023
• Source: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 29, 2018
• Est. primary completion date: December 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• HIV-1 Infection
• Infections

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	BCN Checkpoint, Consorci Sanitari de Terrassa, Germans Trias i Pujol Hospital, Institut d'Investigació Biomèdica de Bellvitge, Institut de Diagnòstic per la Imatge (IDI), IrsiCaixa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Global Cognitive Functioning	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.	From Baseline to Week 48
Secondary	Change in Neuropsychiatric Symptoms	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.	From Baseline to Week 48
Secondary	Change in Daily Living Functioning	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.	From Baseline to Week 48
Secondary	Change in Depressive Symptoms	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.	From baseline to week 48
Secondary	Change in Anxiety Symptoms	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.	From Baseline to Week 48
Secondary	Change in Daily Perceived Stress	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.	From baseline to week 48
Secondary	Change in Quality of Life	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.	From Baseline to Week 48
Secondary	Change in Neuroimaging Markers	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.	From Baseline to Week 48