| Placebo (n = 8) | Active (n = 8) | Total (n = 16) |
---|---|---|---|
Demographics | Â | Â | Â |
Country [n(%)] | Â | Â | Â |
   England | 6 (75) | 6 (75) | 12 (75) |
   Japan | 2 (25) | 2 (25) | 4 (25) |
Gender [n(%)] | Â | Â | Â |
   Male | 4 (50) | 1 (13) | 5 (31) |
Ethnic origin [n(%)] | Â | Â | Â |
   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 | Â | Â | Â |
   mean years (SD) | 61.0 (10.8) | 53.9 (15.5) | 57.4 (13.4) |
Likely mode of infectiona [n(%)] | Â | Â | Â |
   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) |
Clinical Characteristics | Â | Â | Â |
Pain score: scale 0–10 |  |  |  |
   median (range) | 2.2 (0–5) | 2.6 (0–8) | 2.6 (0–8) |
Osame's score [n(%)] | Â | Â | Â |
   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)] | Â | Â | Â |
   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)] | Â | Â | Â |
   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 | Â | Â | Â |
   median (range) | 10.5 (5 – 19) | 9 (1–18) | 9 (1–19) |
Laboratory Measurements* | Â | Â | Â |
HTLV-I proviral loadd (log10 copies/105 PBMCs) | Â | Â | Â |
   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) |