Status:
COMPLETED
Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborating Sponsors:
Institut de Diagnostic per la Imatge
Institut d'Investigació Biomèdica de Bellvitge
Conditions:
HIV-1 Infection
Cognitive Impairment
Eligibility:
All Genders
18-65 years
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 ...
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 bloo...
Eligibility Criteria
Inclusion
- The study criteria for participation in the study will be the following:
- 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
- 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).
Key Trial Info
Start Date :
October 26 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 29 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03835546
Start Date
October 26 2015
End Date
June 29 2018
Last Update
December 13 2023
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