NCT00272480

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 1999

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

January 4, 2006

Last Update Submit

August 24, 2021

Conditions

HTLV-I-associated Myelopathy

Keywords

HAM/TSPHTLV-I-associated myelopathyzidovudinelamivudineantiretroviral therapy

Outcome Measures

Primary Outcomes (5)

  • Timed walk

    Time taken to walk 13m

    6 months

  • Osame's Motor Disability Score

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

    6 months

  • Pain score

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

    6 months

  • Urinary frequency

    Number of times passing urine during the daytime

    6 months

  • HTLV-1 proviral load

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

    6 months

Secondary Outcomes (2)

  • CD25%

    6 months

  • HLA-DR%

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo in HAM/TSP 24

Drug: Placebos

Zidvoudine plus lamivudine

ACTIVE COMPARATOR

Zidvoudine plus lamivudine in HAM/TSP 24

Drug: Zidovudine/lamivudine

Interventions

Zidovudine/lamivudineDRUG
Zidvoudine plus lamivudine
PlacebosDRUG
Placebo

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HTLV-I-associated myelopathy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College

London, W2 1PG, United Kingdom

Location

Related 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

    BACKGROUND

  • 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.

    PMID: 16984654RESULT

MeSH Terms

Conditions

Paraparesis, Tropical Spastic

Interventions

lamivudine, zidovudine drug combination

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsHTLV-I InfectionsDeltaretrovirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory Diseases

Study Officials

  • Graham P Taylor, FRCP

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 6, 2006

Study Start

November 8, 1999

Primary Completion

July 30, 2002

Study Completion

July 30, 2002

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)