Back to resultsZidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
Primary Purpose
HTLV-I-associated Myelopathy
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Zidovudine/lamivudine
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for HTLV-I-associated Myelopathy focused on measuring HAM/TSP, HTLV-I-associated myelopathy, zidovudine, lamivudine, antiretroviral therapy
Eligibility Criteria
Inclusion Criteria: HTLV-I-associated myelopathy Exclusion Criteria: prior exposure to zidovudine or lamivudine on disease modifying therapy under age 16
Sites / Locations
- Imperial College
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Zidvoudine plus lamivudine
Arm Description
Placebo in HAM/TSP 24
Zidvoudine plus lamivudine in HAM/TSP 24
Outcomes
Primary Outcome Measures
Timed walk
Time taken to walk 13m
Osame's Motor Disability Score
0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)
Pain score
11 point Visual Analogue Scale 0 = no pain, 10 = worse pain
Urinary frequency
Number of times passing urine during the daytime
HTLV-1 proviral load
The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells
Secondary Outcome Measures
CD25%
Expression of CD25 on T-cells
HLA-DR%
Expression of HLA-DR on T-cells
Full Information
NCT ID
NCT00272480
First Posted
January 4, 2006
Last Updated
August 24, 2021
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT00272480
Brief Title
Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
Official Title
Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 8, 1999 (Actual)
Primary Completion Date
July 30, 2002 (Actual)
Study Completion Date
July 30, 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HTLV-I-associated Myelopathy
Keywords
HAM/TSP, HTLV-I-associated myelopathy, zidovudine, lamivudine, antiretroviral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in HAM/TSP 24
Arm Title
Zidvoudine plus lamivudine
Arm Type
Active Comparator
Arm Description
Zidvoudine plus lamivudine in HAM/TSP 24
Intervention Type
Drug
Intervention Name(s)
Zidovudine/lamivudine
Intervention Type
Drug
Intervention Name(s)
Placebos
Primary Outcome Measure Information:
Title
Timed walk
Description
Time taken to walk 13m
Time Frame
6 months
Title
Osame's Motor Disability Score
Description
0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)
Time Frame
6 months
Title
Pain score
Description
11 point Visual Analogue Scale 0 = no pain, 10 = worse pain
Time Frame
6 months
Title
Urinary frequency
Description
Number of times passing urine during the daytime
Time Frame
6 months
Title
HTLV-1 proviral load
Description
The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells
Time Frame
6 months
Secondary Outcome Measure Information:
Title
CD25%
Description
Expression of CD25 on T-cells
Time Frame
6 months
Title
HLA-DR%
Description
Expression of HLA-DR on T-cells
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HTLV-I-associated myelopathy
Exclusion Criteria:
prior exposure to zidovudine or lamivudine on disease modifying therapy
under age 16
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham P Taylor, FRCP
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College
City
London
ZIP/Postal Code
W2 1PG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
PubMed Identifier
16984654
Citation
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. 2006 Sep 19;3:63. doi: 10.1186/1742-4690-3-63.
Results Reference
result
Learn more about this trial
Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
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