NCT00272480

Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• HTLV-I-associated Myelopathy

Interventions

Type	Name	Description
DRUG	Zidovudine/lamivudine
DRUG	Placebos

Timeline

• Start date: 1999-11-08
• Primary completion: 2002-07-30
• Completion: 2002-07-30
• First posted: 2006-01-06
• Last updated: 2021-08-25

Locations

1 site across 1 country: United Kingdom