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

NCT03835546 | Completed Results

• 1 other identifier: FLS-ANT-2015-01
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV-1 Infection; Cognitive Impairment

Keywords

Brain; HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Neuropsychiatric Symptoms

  From Baseline to Week 48

• Change in Daily Living Functioning

  From Baseline to Week 48

• Change in Depressive Symptoms

  From baseline to week 48

• Change in Anxiety Symptoms

  From Baseline to Week 48

• Change in Daily Perceived Stress

  From baseline to week 48

Study Arms (3)

Early treated patients

Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy presenting recent HIV-1 infection. Recent HIV-1 infection was defined as having a positive plasma viral load and/or p24 antigen with a negative ELISA or having a positive ELISA and undetermined Western-Blot, or having a positive ELISA and absence of p31 antigen in a positive Western-Blot, or seroconversion ELISA in less than 3 months.

Regularly treated patients

Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy, did not fulfil the criteria for recent HIV-1 infection, and had an estimated time \>6 months reported by the patient and/or by the responsible physician since HIV transmission.

Seronegative volunteers

HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV patients early treated HIV chronically patients non HIV participants

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead
• Institut de Diagnostic per la Imatge: collaborator
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Consorci Sanitari de Terrassa: collaborator
• BCN Checkpoint: collaborator
• Germans Trias i Pujol Hospital: collaborator
• IrsiCaixa: collaborator

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Jose A. Muñoz-Moreno
• Organization: Fundació Lluita contra la SIDA

jmunoz@flsida.org

+34 93 497 84 14

Study Officials

• Jose A. Muñoz-Moreno

  Lluita contra la Sida Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: February 8, 2019
• Study Start: October 26, 2015
• Primary Completion: December 23, 2016
• Study Completion: June 29, 2018
• Last Updated: December 13, 2023
• Results First Posted: June 1, 2020

Record last verified: 2023-11