Trial Outcomes & Findings for Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study (NCT NCT03835546)
NCT ID: NCT03835546
Last Updated: 2023-12-13
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
45 participants
Primary outcome timeframe
From Baseline to Week 48
Results posted on
2023-12-13
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study
Baseline characteristics by cohort
| Measure |
Early Treated Patients
n=12 Participants
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
n=15 Participants
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
n=15 Participants
HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 10 • n=5 Participants
|
31 years
STANDARD_DEVIATION 9 • n=7 Participants
|
32 years
STANDARD_DEVIATION 10 • n=5 Participants
|
32 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 48The 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.
Outcome measures
| Measure |
Early Treated Patients
n=12 Participants
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
n=15 Participants
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
n=15 Participants
HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
|
|---|---|---|---|
|
Change in Global Cognitive Functioning
|
0.08 score on a scale
Standard Deviation 0.26
|
0.31 score on a scale
Standard Deviation 0.28
|
0.25 score on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: From Baseline to Week 48The 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.
Outcome measures
| Measure |
Early Treated Patients
n=12 Participants
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
n=15 Participants
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
n=15 Participants
HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
|
|---|---|---|---|
|
Change in Neuropsychiatric Symptoms
|
-2.90 score on a scale
Standard Deviation 8.76
|
0.33 score on a scale
Standard Deviation 7.58
|
0.30 score on a scale
Standard Deviation 5.77
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Daily 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.
Outcome measures
| Measure |
Early Treated Patients
n=12 Participants
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
n=15 Participants
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
n=15 Participants
HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
|
|---|---|---|---|
|
Change in Daily Living Functioning
|
0.54 score on a scale
Standard Deviation 1.69
|
0.33 score on a scale
Standard Deviation 2.01
|
0.30 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: From baseline to week 48Depressive 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.
Outcome measures
| Measure |
Early Treated Patients
n=12 Participants
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
n=15 Participants
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
n=15 Participants
HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
|
|---|---|---|---|
|
Change in Depressive Symptoms
|
-3.55 score on a scale
Standard Deviation 2.58
|
-0.50 score on a scale
Standard Deviation 3.84
|
-0.60 score on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Anxiety 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.
Outcome measures
| Measure |
Early Treated Patients
n=12 Participants
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
n=15 Participants
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
n=15 Participants
HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
|
|---|---|---|---|
|
Change in Anxiety Symptoms
|
-5.18 score on a scale
Standard Deviation 3.46
|
-2.00 score on a scale
Standard Deviation 2.93
|
-1.30 score on a scale
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: From baseline to week 48Perceived 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.
Outcome measures
| Measure |
Early Treated Patients
n=12 Participants
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
n=15 Participants
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
n=15 Participants
HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
|
|---|---|---|---|
|
Change in Daily Perceived Stress
|
-7.55 score on a scale
Standard Deviation 3.88
|
-6.50 score on a scale
Standard Deviation 9.24
|
1.40 score on a scale
Standard Deviation 4.72
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Quality 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.
Outcome measures
| Measure |
Early Treated Patients
n=12 Participants
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
n=15 Participants
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
n=15 Participants
HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
|
|---|---|---|---|
|
Change in Quality of Life
|
0.18 score on a scale
Standard Deviation 0.40
|
0.08 score on a scale
Standard Deviation 0.51
|
0.10 score on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Neuroimaging 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.
Outcome measures
Outcome data not reported
Adverse Events
Early Treated Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regularly Treated Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Seronegative Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jose A. Muñoz-Moreno
Fundació Lluita contra la SIDA
Phone: +34 93 497 84 14
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place