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Table 1 Baseline characteristics

From: Zidovudine plus lamivudine in Human T-Lymphotropic Virus type-I-associated myelopathy: a randomised trial

  Placebo (n = 8) Active (n = 8) Total (n = 16)
Demographics    
Country [n(%)]    
   England 6 (75) 6 (75) 12 (75)
   Japan 2 (25) 2 (25) 4 (25)
Gender [n(%)]    
   Male 4 (50) 1 (13) 5 (31)
Ethnic origin [n(%)]    
   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    
   mean years (SD) 61.0 (10.8) 53.9 (15.5) 57.4 (13.4)
Likely mode of infectiona [n(%)]    
   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    
Pain score: scale 0–10    
   median (range) 2.2 (0–5) 2.6 (0–8) 2.6 (0–8)
Osame's score [n(%)]    
   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)]    
   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)]    
   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    
   median (range) 10.5 (5 – 19) 9 (1–18) 9 (1–19)
Laboratory Measurements*    
HTLV-I proviral loadd (log10 copies/105 PBMCs)    
   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)
  1. *median (range) unless otherwise specified
  2. a Total exceeds 16 because more than one possible mode of infection was documented in some patients
  3. b One patient could only walk half distance. For the analysis their timed walk was doubled
  4. c One patient in each group is excluded from the analysis because they had an indwelling urinary catheter.
  5. 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
  6. d Baseline data only available on n = 6 in placebo group and n = 7 in active group
  7. e Baseline data only available on n = 7 in placebo group and n = 7 in active group