N/A
Completed N=45
Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study
Source: ClinicalTrials.gov NCT03835546 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Change in Global Cognitive Functioning — 0.08; 0.31; 0.25 score on a scale
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 ( 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Cognitive Functioning |
0.08; 0.31; 0.25 | — |
| SECONDARY Change in Neuropsychiatric Symptoms |
-2.90; 0.33; 0.30 | — |
| SECONDARY Change in Daily Living Functioning |
0.54; 0.33; 0.30 | — |
| SECONDARY Change in Depressive Symptoms |
-3.55; -0.50; -0.60 | — |
| SECONDARY Change in Anxiety Symptoms |
-5.18; -2.00; -1.30 | — |
| SECONDARY Change in Daily Perceived Stress |
-7.55; -6.50; 1.40 | — |
| SECONDARY Change in Quality of Life |
0.18; 0.08; 0.10 | — |
| SECONDARY Change in Neuroimaging Markers |
— | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT03835546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.