- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03835546
Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study (ARBRE)
November 22, 2023 updated by: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
45
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
HIV patients early treated HIV chronically patients non HIV participants
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
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.
|
Seronegative volunteers
HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Global Cognitive Functioning
Time Frame: From Baseline to Week 48
|
The measure used will be NPZ-12 (NeuroPsychological Z-12).
Minimum value: -5 Maximum value: +5.
Mean: 0. Lower score will represent worse global cognitive functioning; higher score will represent better global cognitive functioning.
|
From Baseline to Week 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Neuropsychiatric Symptoms
Time Frame: From Baseline to Week 48
|
The measure used will be a checklist of symptoms involving the central nervous system.
Minimum value: 0; Maximum value: 140.
Lower score will represent better neuropsychiatric status; higher score will represent worse neuropsychiatric status.
|
From Baseline to Week 48
|
Change in Daily Living Functioning
Time Frame: From Baseline to Week 48
|
Daily living functioning will be measured by a self-reported scale indicating daily living areas impaired.
Minimum score: 0; Maximum score: 13.
A lower score will represent better daily functioning; a higher score will represent worse daily functioning.
|
From Baseline to Week 48
|
Change in Depressive Symptoms
Time Frame: From baseline to week 48
|
Depressive symptoms will be measured by a self-reported scale that will assess depressive symptoms.
Minimum score: 0; Maximum score: 21.
A lower score will represent better depressive status; a higher score will represent worse depressive status.
|
From baseline to week 48
|
Change in Anxiety Symptoms
Time Frame: From Baseline to Week 48
|
Anxiety symptoms will be measured by a self-reported scale that will assess anxiety symptoms.
Minimum score: 0; Maximum score: 21.
A lower score will represent better anxiety status; a higher score will represent worse anxiety status.
|
From Baseline to Week 48
|
Change in Daily Perceived Stress
Time Frame: From baseline to week 48
|
Perceived stress will be measured by a self-reported scale that will assess daily symptoms of perceived stress.
Minimum score: 0; Maximum score: 40.
A lower score will represent better perceived stress status; a higher score will represent worse perceived stress status.
|
From baseline to week 48
|
Change in Quality of Life
Time Frame: From Baseline to Week 48
|
Quality of life will be measured by a self-reported scale that will assess global quality of life.
Minimum score: 1; Maximum score: 4. A lower score will represent worse quality of life; a higher score will represent better quality of life.
|
From Baseline to Week 48
|
Change in Neuroimaging Markers
Time Frame: From Baseline to Week 48
|
Neuroimaging markers will be assessed by 3T magnetic resonance imaging (MRI).
The specific markers will be caudate nucleus, ventral striatum/nucleus accumbens, putamen, pallidum, thalamus, dorsomedial, dorsolateral, cingulate, ventromedial, medial orbitofrontal, and lateral orbitofrontal cortex.
The outcome will be based on change in any of them.
|
From Baseline to Week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jose A. Muñoz-Moreno, Lluita contra la Sida Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2015
Primary Completion (Actual)
December 23, 2016
Study Completion (Actual)
June 29, 2018
Study Registration Dates
First Submitted
September 25, 2018
First Submitted That Met QC Criteria
February 7, 2019
First Posted (Actual)
February 8, 2019
Study Record Updates
Last Update Posted (Actual)
December 13, 2023
Last Update Submitted That Met QC Criteria
November 22, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLS-ANT-2015-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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