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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo in HAM/TSP 24 |
|
| Zidvoudine plus lamivudine | Active Comparator | Zidvoudine plus lamivudine in HAM/TSP 24 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zidovudine/lamivudine | Drug |
| ||
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Timed walk | Time taken to walk 13m | 6 months |
| Osame's Motor Disability Score | 0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk) | 6 months |
| Pain score | 11 point Visual Analogue Scale 0 = no pain, 10 = worse pain | 6 months |
| Urinary frequency | Number of times passing urine during the daytime | 6 months |
| HTLV-1 proviral load | The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| CD25% | Expression of CD25 on T-cells | 6 months |
| HLA-DR% | Expression of HLA-DR on T-cells | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graham P Taylor, FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College | London | W2 1PG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Taylor GP et al The Bridge Study - A double-blind, placebo controlled trial of zidovudine plus lamivudine for the treatment of patients with HTLV-I-associated myelopathy AIDS Research and Human Retroviruses 2003;19 (suppl 1) #O23 | ||
| 16984654 | Result | Taylor GP, Goon P, Furukawa Y, Green H, Barfield A, Mosley A, Nose H, Babiker A, Rudge P, Usuku K, Osame M, Bangham CR, Weber JN. Zidovudine plus lamivudine in Human T-Lymphotropic Virus type-I-associated myelopathy: a randomised trial. Retrovirology. 2006 Sep 19;3:63. doi: 10.1186/1742-4690-3-63. |
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| ID | Term |
|---|---|
| D015493 | Paraparesis, Tropical Spastic |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D015490 | HTLV-I Infections |
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| ID | Term |
|---|---|
| C109078 | lamivudine, zidovudine drug combination |
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|
| D006800 |
| Deltaretrovirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |