HTLV-I-associated Myelopathy
Conditions
Keywords
HAM/TSP, HTLV-I-associated myelopathy, zidovudine, lamivudine, antiretroviral therapy
Brief summary
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
Detailed description
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
Interventions
DRUGPlacebos
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* HTLV-I-associated myelopathy
Exclusion criteria
* prior exposure to zidovudine or lamivudine on disease modifying therapy * under age 16
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osame's Motor Disability Score | 6 months | 0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk) |
| Urinary frequency | 6 months | Number of times passing urine during the daytime |
| HTLV-1 proviral load | 6 months | The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells |
| Timed walk | 6 months | Time taken to walk 13m |
| Pain score | 6 months | 11 point Visual Analogue Scale 0 = no pain, 10 = worse pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HLA-DR% | 6 months | Expression of HLA-DR on T-cells |
| CD25% | 6 months | Expression of CD25 on T-cells |
Countries
United Kingdom
Outcome results
None listed