Clinical trial NCT03835546: Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infection
Cognitive Impairment
Keywords: Brain
HIV-1 Infection
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
Collaborators: name: Institut de Diagnostic per la Imatge
name: Institut d'Investigació Biomèdica de Bellvitge
name: Consorci Sanitari de Terrassa
name: BCN Checkpoint
name: Germans Trias i Pujol Hospital
name: IrsiCaixa
First posted: 2019-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV patients early treated HIV chronically patients non HIV participants

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Global Cognitive Functioning
timeFrame: From Baseline to Week 48
Secondary outcomes:
measure: Change in Neuropsychiatric Symptoms
timeFrame: From Baseline to Week 48
measure: Change in Daily Living Functioning
timeFrame: From Baseline to Week 48
measure: Change in Depressive Symptoms
timeFrame: From baseline to week 48
measure: Change in Anxiety Symptoms
timeFrame: From Baseline to Week 48
measure: Change in Daily Perceived Stress
timeFrame: From baseline to week 48
measure: Change in Quality of Life
timeFrame: From Baseline to Week 48
measure: Change in Neuroimaging Markers
timeFrame: From Baseline to Week 48
Other outcomes:
Locations:
Study officials:
affiliation: Lluita contra la Sida Foundation
name: Jose A. Muñoz-Moreno
role: PRINCIPAL_INVESTIGATOR
References: