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

NCT03835546 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2023-12-13

Study results available
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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

Sponsors & Collaborators

  • Institut de Diagnostic per la Imatge

    collaborator OTHER

  • Institut d'Investigació Biomèdica de Bellvitge

    collaborator OTHER

  • Consorci Sanitari de Terrassa

    collaborator OTHER

  • BCN Checkpoint

    collaborator INDUSTRY

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • IrsiCaixa

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Jose A. Muñoz-Moreno · Lluita contra la Sida Foundation

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-26
Primary Completion
2016-12-23
Completion
2018-06-29

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03835546 on ClinicalTrials.gov