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

NCT ID: NCT03835546

Last Updated: 2023-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-26

Study Completion Date

2018-06-29

Brief Summary

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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

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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.

Conditions

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HIV-1 Infection Cognitive Impairment

Keywords

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Brain HIV-1 Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Seronegative volunteers

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

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Diagnostic per la Imatge

OTHER

Sponsor Role collaborator

Institut d'Investigació Biomèdica de Bellvitge

OTHER

Sponsor Role collaborator

Consorci Sanitari de Terrassa

OTHER

Sponsor Role collaborator

BCN Checkpoint

INDUSTRY

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

IrsiCaixa

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose A. Muñoz-Moreno

Role: PRINCIPAL_INVESTIGATOR

Lluita contra la Sida Foundation

Other Identifiers

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FLS-ANT-2015-01

Identifier Type: -

Identifier Source: org_study_id