|
Baseline characteristics |
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| Placebo (n = 8) |
Active (n = 8) |
Total (n = 16) |
|
|
|
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| Demographics |
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| Country [n(%)] |
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| England |
6 (75) |
6 (75) |
12 (75) |
| Japan |
2 (25) |
2 (25) |
4 (25) |
| Gender [n(%)] |
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| Male |
4 (50) |
1 (13) |
5 (31) |
| Ethnic origin [n(%)] |
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| Afro-Caribbean |
5 (63) |
5 (63) |
10 (63) |
| Indian |
1 (13) |
0 (0) |
1 (6) |
| Japanese |
2 (25) |
2 (25) |
4 (25) |
| Persian |
0 (0) |
1 (13) |
1 (6) |
| Age at randomisation |
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| mean years (SD) |
61.0 (10.8) |
53.9 (15.5) |
57.4 (13.4) |
| Likely mode of infectiona [n(%)] |
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| Mother to child |
3 (30) |
5 (33) |
8 (32) |
| Blood transfusion |
1 (10) |
2 (13) |
3 (12) |
| Sexual intercourse |
2 (20) |
6 (40) |
8 (32) |
| Unknown |
4 (40) |
2 (13) |
6 (24) |
|
|
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| Clinical Characteristics |
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| Pain score: scale 0–10 |
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| median (range) |
2.2 (0–5) |
2.6 (0–8) |
2.6 (0–8) |
| Osame's score [n(%)] |
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| 0 – 4 (Unaided walk) |
3 (38) |
3 (38) |
6 (38) |
| 5 – 8 (Needs aid to walk) |
4 (50) |
3 (38) |
7 (44) |
| 9 – 13 (Unable to walk) |
1 (13) |
2 (25) |
3 (19) |
| Time to walk 13 m in seconds [mean (SD)] |
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| 0 – 4 (Unaided walk) |
19 (13) |
13 (2) |
16 (9) |
| 5 – 8 (Needs aid to walk) |
82b (65) |
112 (112) |
95b (81) |
| Bladder functionc [median (range)] |
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| Daytime frequency |
5 (4–8) |
4.5 (2–8) |
5 (2–8) |
| Nocturia |
4 (3.5–4) |
2 (0.5–4) |
4 (0.5–4) |
| Duration of symptoms in years |
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| median (range) |
10.5 (5 – 19) |
9 (1–18) |
9 (1–19) |
|
|
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| Laboratory Measurements* |
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| HTLV-I proviral loadd (log10 copies/105 PBMCs) |
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| mean (SD) |
3.57 (0.44) |
3.76 (0.39) |
3.67 (0.41) |
| Total lymphocytese (106/L) |
1600 (1250–2600) |
1800 (1250–3000) |
1775 (1250–3000) |
| CD3 lymphocytese (106/L) |
1165(488–2018) |
1240(430–2144) |
1190(430–2144) |
| CD3e % |
71 (35–81) |
69 (34–90) |
71 (34–90) |
| CD4e lymphocytes (106/L) |
802(340–1670) |
801(334–1375) |
801(334–1670) |
| CD4e % |
39 (25–67) |
44 (27–59) |
44 (25–67) |
| CD8e lymphocytes (106/L) |
375 (149–941) |
185 (96–840) |
362 (96–941) |
| CD8e % |
27 (11–36) |
10 (6–46) |
21 (6–46) |
| CD25d % |
3 (2–26) |
7 (2–33) |
3 (2–33) |
| CD69d % |
8 (4–10) |
7 (4–14) |
7 (4–14) |
| CD71d % |
9 (3–12) |
7 (3–18) |
8 (3–18) |
| HLA-DR% |
20 (13–40) |
9 (5–16) |
15 (5–40) |
|
*median (range) unless otherwise specified a Total exceeds 16 because more than one possible mode of infection was documented in some patients b One patient could only walk half distance. For the analysis their timed walk was doubled c One patient in each group is excluded from the analysis because they had an indwelling urinary catheter. A further 5 patients (3 in placebo group, 2 in active group) have missing nightly frequencies. Values given as average daily/nightly urinary frequency between screening and week 0 d Baseline data only available on n = 6 in placebo group and n = 7 in active group e Baseline data only available on n = 7 in placebo group and n = 7 in active group | |||
Taylor et al. Retrovirology 2006 3:63 doi:10.1186/1742-4690-3-63 |
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