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

HTLV-I-associated Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272480
• Other study ID #: BRIDGE1.0
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 8, 1999
• Est. completion date: July 30, 2002

Study information

• Verified date: August 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 30, 2002
• Est. primary completion date: July 30, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• HTLV-I-associated myelopathy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• HTLV-I-associated Myelopathy
• Spinal Cord Diseases

Intervention

Drug:
• Zidovudine/lamivudine

• Placebos

Locations

Country	Name	City	State
United Kingdom	Imperial College	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Taylor GP et al The Bridge Study - A double-blind, placebo controlled trial of zidovudine plus lamivudine for the treatment of patients with HTLV-I-associated myelopathy AIDS Research and Human Retroviruses 2003;19 (suppl 1) #O23

Taylor GP, Goon P, Furukawa Y, Green H, Barfield A, Mosley A, Nose H, Babiker A, Rudge P, Usuku K, Osame M, Bangham CR, Weber JN. Zidovudine plus lamivudine in Human T-Lymphotropic Virus type-I-associated myelopathy: a randomised trial. Retrovirology. 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed walk	Time taken to walk 13m	6 months
Primary	Osame's Motor Disability Score	0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)	6 months
Primary	Pain score	11 point Visual Analogue Scale 0 = no pain, 10 = worse pain	6 months
Primary	Urinary frequency	Number of times passing urine during the daytime	6 months
Primary	HTLV-1 proviral load	The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells	6 months
Secondary	CD25%	Expression of CD25 on T-cells	6 months
Secondary	HLA-DR%	Expression of HLA-DR on T-cells	6 months