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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT00272480 |
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Date of registration:
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04/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
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Scientific title:
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Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial |
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Date of first enrolment:
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November 8, 1999 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00272480 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Graham P Taylor, FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imperial College London |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HTLV-I-associated myelopathy
Exclusion Criteria:
- prior exposure to zidovudine or lamivudine on disease modifying therapy
- under age 16
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HTLV-I-associated Myelopathy
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Intervention(s)
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Drug: Placebos
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Drug: Zidovudine/lamivudine
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Primary Outcome(s)
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HTLV-1 proviral load
[Time Frame: 6 months]
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Osame's Motor Disability Score
[Time Frame: 6 months]
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Pain score
[Time Frame: 6 months]
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Timed walk
[Time Frame: 6 months]
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Urinary frequency
[Time Frame: 6 months]
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Secondary Outcome(s)
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CD25%
[Time Frame: 6 months]
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HLA-DR%
[Time Frame: 6 months]
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Secondary ID(s)
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BRIDGE1.0
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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