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

Phase 2

Completed

• Conditions: HTLV-I-associated Myelopathy
• Interventions: Drug: Placebos; Drug: Zidovudine/lamivudine

• Registration Number: NCT00272480
• Lead Sponsor: Imperial College London

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 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

Study Timeline

• Study Start: 1999-11-08
• Primary Completion: 2002-07-30
• Study Completion: 2002-07-30
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-04
• Study First Posted: 2006-01-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• HTLV-I-associated myelopathy

Exclusion Criteria

• prior exposure to zidovudine or lamivudine on disease modifying therapy
• under age 16

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Placebo in HAM/TSP 24
Zidvoudine plus lamivudine	Zidovudine/lamivudine	Zidvoudine plus lamivudine in HAM/TSP 24

Primary Outcome Measures

Name	Time	Method
Osame's Motor Disability Score	6 months	0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)
Pain score	6 months	11 point Visual Analogue Scale 0 = no pain, 10 = worse pain
Urinary frequency	6 months	Number of times passing urine during the daytime
HTLV-1 proviral load	6 months	The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells
Timed walk	6 months	Time taken to walk 13m

Secondary Outcome Measures

Name	Time	Method
HLA-DR%	6 months	Expression of HLA-DR on T-cells
CD25%	6 months	Expression of CD25 on T-cells

Trial Locations

Locations (1)

Imperial College; 🇬🇧 London, United Kingdom