Table 1.
Demographic and clinical characteristics Baseline and W24, by arm allocation
| Overall n = 28 |
MARAND-X n = 15 |
SOC n = 13 |
p-value | |
|---|---|---|---|---|
| Demographics | ||||
| Age (years) | 57 (53 – 60) | 57 (53 – 61) | 55 (53 –59) | 0.729 |
| Gender (male) | 21 (75) | 10 (66.7) | 11 (84.6) | 0.39 |
| Ethnicity | 1 | |||
| African | 1 (3.6) | 1 (6.7) | 0 (0) | |
| Caucasian | 25 (89.3) | 13 (86.7) | 12 (92.3) | |
| Latin | 2 (7.1) | 1 (6.7) | 1 (7.7) | |
| Education | 10 (8 – 13) | 8 (7 – 12) | 13 (10 – 13) | 0.159 |
| BMI | 24 (23 – 27) | 24 (22 –25) | 25 (24 – 29) | 0.084 |
| Comorbidities | ||||
| Hypertension | 6 (21.4) | 3 (20) | 3 (23) | 1 |
| Type 2 Diabetes | 1 (3.6) | 1 (6.7) | 0 (0) | 1 |
| Smoking | 7 (25) | 4 (26.7) | 3 (23.1) | 1 |
| Depressive disorder | 6 (21.4) | 5 (33.3) | 1 (7.7) | 0.173 |
| HBV co-infection | 4 (14.3) | 1 (6.7) | 3 (23.1) | 0.311 |
| HCV former infection | 7 (25) | 4 (26.7) | 3 (23.1) | 1 |
| eGFR-EPI-CKD (ml/min/1.73m2) | 92 (78 – 100) | 91 (81 – 100) | 95 (75 – 100) | 0.964 |
| HIV-1 infection | ||||
| Time from HIV-1 diagnosis (years) | 16 (8 – 25) | 14 (7.5 – 24) | 16 (8 – 25) | 0.344 |
| VL < 50 cp/mL | ||||
| Plasma | 28 (100) | 15 (100) | 13 (100) | 1 |
| CSF | 28 (100) | 15 (100) | 13 (100) | 1 |
| Time with VL < 50 cp/mL (years) | 11 (5.5 – 15) | 10 (5 – 13) | 13 (6.8 – 16) | 0.352 |
| CD4+ T cells | ||||
| Cells count nadir (cells/μL) | 300 (150 – 420) | 320 (150 –400) | 250 (180 –440) | 0.89 |
| Current cell count (cells/μL) | 710 (480 – 890) | 560 (450 – 800) | 740 (540 – 1000) | 0.254 |
| Current Percentages (%) | 32 (24 – 42) | 31 (24 – 40) | 36 (28 – 42) | 0.549 |
| Current CD4/CD8 ratio | 0.8 (0.65 – 1.5) | 0.8 (0.5 – 1.3) | 0.8 (0.7 – 1.6) | 0.562 |
| Pre-screening ARV regimen | 0.109 | |||
| INSTI + 2 NRTI | 15 (57.1) | 10 (66.7) | 5 (38.5) | |
| NNRTI + 2 NRTI | 9 (28.6) | 3 (20) | 6 (46.2) | |
| PI + 2 NRTI | 2 (7.1) | 0 (0) | 2 (15.4) | |
| INSTI + PI | 2 (7.1) | 2 (13.3) | 0 (0) | |
| CPE | 6 (6 – 8) | 6 (6 – 8) | 6 (6 – 8) | 1 |
| Neurocognitive disorder | ||||
| HAND | 0.6 | |||
| ANI | 24 (85.7) | 12 (80) | 12 (92.3) | |
| MND | 4 (14.3) | 3 (20) | 1 (7.7) | |
| HAD | 0 (0) | 0 (0) | 0 (0) | |
| GPS | 2.5 (1.5 – 3.1) | 2.3 (1.7 – 3.1) | 2.6 (1.5 – 3.0) | 1 |
Data are presented as median (interquartile ranges) or number (percentage). ANI Asymptomatic neurocognitive impairment, ARV antiretroviral, BMI body mass index, CD cluster ofdifferentiation, CPE CNS penetration-effectivness score, eGFR estimated glomerular filtrate rate, GPS Global Performance Score, HAD HIV associated dementia, HAND HIV associated neurocognitive disorder, INSTI Integrase strand transfer inhibitors, MARAND-X Interventional arm, MND Mild neurocognitive disorder, NNRTI non-nucleosidic reverse transcriptase inhibitors, NRTI nucleosidic reverse transcriptase inhibitors, p p-value, PI protease inhibitors, SOC Standard of care (control arm), VL HIV-1 viral load