Parameters at LP Study population (n=300) CSF escape (n=51) No CSF escape (n=249) P
Age, years 49 (43-55) 48 (39-52) 50 (43-56) 0.006
Male sex, n 201 (67.0%) 28 (54.9%) 173 (69.5%) 0.044
Enrollment site, n Torino
Spallanzani
Brescia
Milano
Brighton
Sapienza
113 (37.7%) 89 (29.6%) 52 (17.3%) 23 (7.7%) 14 (4.7%) 9 (3.0%) 20 (39.2%) 23 (45.1%) 5 (9.8%) 3 (5.9%) 0 0 93 (37.3%) 66 (26.5%) 47 (18.9%) 20 (8.0%) 14 (5.6%) 9 (3.6%)
0.075
Calendar year, n 2016-2021
2011-2015
2006-2010
2001-2005
116 (38.7%) 144 (48.0%) 30 (10.0%) 10 (3.3%) 13 (25.5%) 27 (52.9%) 7 (13.7%) 4 (7.8%) 103 (41.4%) 117 (47.0%) 23 (9.2%) 6 (2.4%)
0.012
LP indication, n RP
CC without CNS involvement
NCI
50 (16.7%) 140 (46.7%) 110 (36.6%) 10 (19.6%) 21 (41.2%) 20 (39.2%) 40 (16.1%) 119 (47.8%) 90 (36.1%)
0.969
Plasma HIV-RNA<50 cp/mL, n 202 (67.3%) 35 (68.6%) 167 (67.1%) 0.829
Plasma HIV-RNA, Log10 cp/mL Overall
When detectable
1.69 (1.69-2.15) 2.85 (2.16-4.51) 1.69 (1.69-2.16) 2.44 (2.18-3.10) 1.69 (1.69-2.14) 3.19 (2.15-5.28) 0.958 0.172
CSF HIV-RNA<50 cp/mL, n 195 (65.0%) 0 195 (78.3%) -
CSF HIV-RNA, Log10 cp/mL Overall
When detectable
1.69 (1.69-2.10) 2.54 (2.07-3.49) 2.18 (1.97-3.62) 2.18 (1.97-3.62) 1.69 (1.69-1.69) 2.63 (2.16-3.45) <0.001 0.201
Type of ART regimen, n PI-2NRTIs
nNRTI-2NRTIs
INSTI-2NRTIs
3 classes-based regimens
≥4 drugs-based regimens
Mono-dual regimens
130 (43.3%) 57 (19.0%) 37 (12.3%) 13 (4.3%) 30 (10.0%) 33 (11.0%) 27 (52.9%) 10 (19.6%) 3 (5.9%) 3 (5.9%) 3 (5.9%) 5 (9.8%) 103 (41.4%) 47 (18.9%) 34 (13.6%) 10 (4.0%) 27 (10.8%) 28 (11.2%)
0.123
PI-including ART, n PI-based mono/dual regimens, n PI-2NRTIs, n PI-based three-classes regimens, n PI-based ≥4 drugs-based regimens, n 195 (65.0%) 29/33 (87.9%) 130/224 (58.0%) 12/13 (92.3%) 24/30 (80.0%) 38 (74.5%) 5/5 (100%) 27/40 (67.5%) 3/3 (100%) 3/3 (100%) 157 (63.0%) 24/28 (85.7%) 103/184 (56.0%) 9/10 (90.0%) 21/27 (77.8%) 0.119 0.999 0.181 0.999 0.999
Number of ARVs Number of ARVs, n 1-2 drugs
3 drugs
4-5 drugs
3 (3-3) 33 (11.0%) 237 (79.0%) 30 (10.0%) 3 (3-3) 5 (9.8%) 43 (84.3%) 3 (5.9%) 3 (3-3) 28 (11.2%) 194 (77.9%) 27 (10.8%) 0.412 0.765 0.307 0.283
On first ART regimen, n 110 (36.7%) 14 (27.4%) 96 (38.6%) 0.135
Current CD4+ T-cells count, cells/µL 310 (139-554) 310 (215-567) 310 (122-553) 0.958
Nadir CD4+ T-cells count, cells/µc Nadir CD4+ T-cells count, n <100
100-200
201-350
351-500
>500
86 (26-199) 159 (53.0%) 68 (22.7%) 43 (14.3%) 20 (6.7%) 10 (3.3%) 80 (13-166) 32 (62.7%) 10 (19.6%) 8 (15.7%) 0 1 (2.0%) 97 (28-205) 127 (51.0%) 58 (23.3%) 35 (14.1%) 20 (8.0%) 9 (3.6%) 0.138 0.084
CD4/CD8 ratio 0.4 (0.2-0.8) 0.4 (0.3-0.8) 0.4 (0.2-0.7) 0.879
Duration of ART, years Duration of ART, n 1-2 years
3-5 years
6-10 years
>10 years
5 (2-8) 92 (30.7%) 74 (24.7%) 82 (27.3%) 52 (17.3%) 4 (2-6) 18 (35.3%) 17 (33.3%) 14 (27.4%) 2 (3.9%) 5 (2-9) 74 (29.7%) 57 (22.9%) 68 (27.3%) 50 (20.1%) 0.036 0.030
Duration of current ART, months Duration of current ART, n <1 year
1-2 years
3-10 years
19 (10-43) 144 (48.0%) 82 (27.3%) 74 (24.7%) 14 (9-28) 27 (52.9%) 13 (25.5%) 11 (21.6%) 19 (10-46) 117 (47.0%) 69 (27.7%) 63 (25.3%) 0.219 0.434
Plasma HGRT, n RT RAMs
PI RAMs
107 (35.7%) 31 (10.3%) 27 (52.9%) 9 (17.6%) 80 (32.1%) 22 (8.8%) 0.005 0.060
Total number of plasma RAMs, RT
PI
0 (0-2) 0 (0-0) 1 (0-3) 0 (0-0) 0 (0-1) 0 (0-0) 0.190 0.156
CSF HGRT, n RT RAMs
PI RAMs
24/63 (38.1%) 8/63 (12.7%) 12/21 (57.1%) 5/21 (23.8%) 12/42 (28.6%) 3/42 (7.1%) 0.029 0.063
Total number of CSF RAMs, RT
PI
0 (0-1) 0 (0-0) 1 (0-3) 0 (0-1) 0 (0-1) 0 (0-0) 0.177 0.141
CPE score 7 (7-8) 7 (7-8) 7 (7-8) 0.921