NCT03835546: ARBRE

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

Completed Results posted Last updated 13 December 2023

What this trial tests

trial in HIV-1 Infection in 45 participants. Completed in 29 June 2018.

Timeline

26 October 2015

Primary endpoint
23 December 2016

29 June 2018

Quick facts

Lead sponsor	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	45
Start date	26 October 2015
Primary completion	23 December 2016
Estimated completion	29 June 2018

Conditions studied

• HIV-1 Infection — all drugs for HIV-1 Infection →
• Cognitive Impairment — all drugs for Cognitive Impairment →

Sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia — full company profile →

Who can join

Adults 18 to 65, any sex, with HIV-1 Infection or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Global Cognitive Functioning Primary · 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.

Group	Value	95% CI
Early Treated Patients	0.08	± 0.26
Regularly Treated Patients	0.31	± 0.28
Seronegative Volunteers	0.25	± 0.19

Change in Neuropsychiatric Symptoms Secondary · 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.

Group	Value	95% CI
Early Treated Patients	-2.90	± 8.76
Regularly Treated Patients	0.33	± 7.58
Seronegative Volunteers	0.30	± 5.77

Change in Daily Living Functioning Secondary · 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.

Group	Value	95% CI
Early Treated Patients	0.54	± 1.69
Regularly Treated Patients	0.33	± 2.01
Seronegative Volunteers	0.30	± 0.82

Change in Depressive Symptoms Secondary · 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.

Group	Value	95% CI
Early Treated Patients	-3.55	± 2.58
Regularly Treated Patients	-0.50	± 3.84
Seronegative Volunteers	-0.60	± 1.43

Change in Anxiety Symptoms Secondary · 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.

Group	Value	95% CI
Early Treated Patients	-5.18	± 3.46
Regularly Treated Patients	-2.00	± 2.93
Seronegative Volunteers	-1.30	± 2.49

Change in Daily Perceived Stress Secondary · 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.

Group	Value	95% CI
Early Treated Patients	-7.55	± 3.88
Regularly Treated Patients	-6.50	± 9.24
Seronegative Volunteers	1.40	± 4.72

Change in Quality of Life Secondary · 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.

Group	Value	95% CI
Early Treated Patients	0.18	± 0.40
Regularly Treated Patients	0.08	± 0.51
Seronegative Volunteers	0.10	± 0.73

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sirtuin-2, NAD-Dependent Deacetylase, Is a New Potential Therapeutic Target for HIV-1 Infection and HIV-Related Neurological Dysfunction.
   Duran-Castells C, Llano A, Kawana-Tachikawa A, Prats A, et al · · 2023 · cited 10× · PMID 36719240 · DOI 10.1128/jvi.01655-22
2. Effects of integrase inhibitor-based antiretroviral therapy on brain outcomes according to time since acquisition of HIV-1 infection.
   Prats A, Martínez-Zalacaín I, Mothe B, Negredo E, et al · · 2021 · cited 10× · PMID 34050221 · DOI 10.1038/s41598-021-90678-6