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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
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Retrovirology

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