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

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

Status: Completed

Conditions: Cognitive Impairment; HIV-1 Infection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03835546

FLS-ANT-2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

45 participants in 3 patient groups

Early treated patients

Description:

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

Description:

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

Description:

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