Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Timed walk
研究概览
简要总结
To determine whether the use of two antiviral agents in combination will be better than placebo in the treatment of an inflammatory sidease of the spinal cord caused by HTLV-I
详细描述
Randomised, double-blind, placebo-controlled two centre study of zidvoudine plus lamivudine in HAM/TSP 24 patients randomised 1:1 2-4 week lead-in 6 months randomised phase followed by 6 months open-label therapy with active drug Primary endpoint: clinical Secondary endpoints: virological and immunological
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HTLV-I-associated myelopathy
排除标准
- •prior exposure to zidovudine or lamivudine on disease modifying therapy
- •under age 16
研究组 & 干预措施
Placebo
Placebo in HAM/TSP 24
干预措施: Placebos (Drug)
Zidvoudine plus lamivudine
Zidvoudine plus lamivudine in HAM/TSP 24
干预措施: Zidovudine/lamivudine (Drug)
结局指标
主要结局
Timed walk
时间窗: 6 months
Time taken to walk 13m
Osame's Motor Disability Score
时间窗: 6 months
0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)
Pain score
时间窗: 6 months
11 point Visual Analogue Scale 0 = no pain, 10 = worse pain
Urinary frequency
时间窗: 6 months
Number of times passing urine during the daytime
HTLV-1 proviral load
时间窗: 6 months
The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells
次要结局
- HLA-DR%(6 months)
- CD25%(6 months)