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