Clinical Trial: Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
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 Summary: 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
Sponsor: Imperial College London
Current Primary Outcome:
- Clinical:
- Timed walk
- Pain score
- Urinary frequency
- Bowel function
- Disability scale
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Viral load
- Markers of inflammation
- Markers of proliferation
Original Secondary Outcome: Same as current
Information By: Imperial College London
Dates:
Date Received: January 4, 2006
Date Started: November 1999
Date Completion: November 2001
Last Updated: May 27, 2015
Last Verified: January 2006