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

Imperial College London16 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HTLV-I-associated Myelopathy

Interventions

Zidovudine/lamivudineDRUG

PlacebosDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HTLV-I-associated myelopathy Exclusion Criteria: * prior exposure to zidovudine or lamivudine on disease modifying therapy * under age 16

Locations (1)

Imperial College

London, United Kingdom

Outcomes

Primary Outcomes

Timed walk

Time taken to walk 13m

Time frame: 6 months

Osame's Motor Disability Score

0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)

Time frame: 6 months

Pain score

11 point Visual Analogue Scale 0 = no pain, 10 = worse pain

Time frame: 6 months

Urinary frequency

Number of times passing urine during the daytime

Time frame: 6 months

HTLV-1 proviral load

The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells

Time frame: 6 months

Secondary Outcomes

CD25%

Expression of CD25 on T-cells

Time frame: 6 months

HLA-DR%

Expression of HLA-DR on T-cells

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.