HIV-1 InfectionARBRENCT03835546
Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study
An observational study of HIV-1 Infection and Cognitive Impairment, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1 Infection, Cognitive Impairment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2015to 29 Jun 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV patients early treated HIV chronically patients non HIV participants
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV-1 Infection, Cognitive Impairment
- Keywords
- Brain, HIV-1 Infection
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Cognitive Functioning
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.
Measured: From Baseline to Week 48
Secondary outcomes (7)
Change in Neuropsychiatric Symptoms
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.
Measured: From Baseline to Week 48
Change in Daily Living Functioning
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.
Measured: From Baseline to Week 48
Change in Depressive Symptoms
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.
Measured: From baseline to week 48
Change in Anxiety Symptoms
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.
Measured: From Baseline to Week 48
Change in Daily Perceived Stress
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.
Measured: From baseline to week 48
Change in Quality of Life
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.
Measured: From Baseline to Week 48
Change in Neuroimaging Markers
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.
Measured: From Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start26 Oct 2015
- Primary completion23 Dec 2016
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Diagnostic per la Imatge, Institut d'Investigació Biomèdica de Bellvitge, Consorci Sanitari de Terrassa, BCN Checkpoint, Germans Trias i Pujol Hospital, IrsiCaixa
- Responsible party
- Sponsor
- Investigators
- Jose A. Muñoz-Moreno, Principal investigator, Lluita contra la Sida Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835546
- Sponsor's protocol ID
- FLS-ANT-2015-01
- Acronym
- ARBRE
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2018
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03835546
- Acronym / sponsor ID
- ARBRE / FLS-ANT-2015-01
- Conditions
- HIV-1 Infection, Cognitive Impairment
- Keywords
- Brain, HIV-1 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- Institut de Diagnostic per la Imatge, Institut d'Investigació Biomèdica de Bellvitge, Consorci Sanitari de Terrassa, BCN Checkpoint, Germans Trias i Pujol Hospital, IrsiCaixa
- Study start
- 26 Oct 2015 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Posted 1 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV patients early treated HIV chronically patients non HIV participants
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Change in Neuropsychiatric Symptoms
Time frame: From Baseline to Week 48
Change in Daily Living Functioning
Time frame: From Baseline to Week 48
Change in Depressive Symptoms
Time frame: From baseline to week 48
Change in Anxiety Symptoms
Time frame: From Baseline to Week 48
Change in Daily Perceived Stress
Time frame: From baseline to week 48
Change in Quality of Life
Time frame: From Baseline to Week 48
Change in Neuroimaging Markers
Time frame: From Baseline to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A. Muñoz-Moreno principal investigator
Lluita contra la Sida Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 Infection and Cognitive Impairment, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Cognitive Functioning (time frame: From Baseline to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.