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

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ClinicalTrials.gov Identifier: NCT00272480
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
HTLV-I-associated Myelopathy Drug: Zidovudine/lamivudine Drug: Placebos Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
Actual Study Start Date : November 8, 1999
Actual Primary Completion Date : July 30, 2002
Actual Study Completion Date : July 30, 2002


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo in HAM/TSP 24
Drug: Placebos
Active Comparator: Zidvoudine plus lamivudine
Zidvoudine plus lamivudine in HAM/TSP 24
Drug: Zidovudine/lamivudine



Primary Outcome Measures :
  1. Timed walk [ Time Frame: 6 months ]
    Time taken to walk 13m

  2. Osame's Motor Disability Score [ Time Frame: 6 months ]
    0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)

  3. Pain score [ Time Frame: 6 months ]
    11 point Visual Analogue Scale 0 = no pain, 10 = worse pain

  4. Urinary frequency [ Time Frame: 6 months ]
    Number of times passing urine during the daytime

  5. HTLV-1 proviral load [ Time Frame: 6 months ]
    The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells


Secondary Outcome Measures :
  1. CD25% [ Time Frame: 6 months ]
    Expression of CD25 on T-cells

  2. HLA-DR% [ Time Frame: 6 months ]
    Expression of HLA-DR on T-cells



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HTLV-I-associated myelopathy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272480


Locations
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United Kingdom
Imperial College
London, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Graham P Taylor, FRCP Imperial College London

Publications of Results:
Other Publications:
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

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00272480     History of Changes
Other Study ID Numbers: BRIDGE1.0
First Posted: January 6, 2006    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imperial College London:
HAM/TSP
HTLV-I-associated myelopathy
zidovudine
lamivudine
antiretroviral therapy

Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Paraparesis, Tropical Spastic
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Lamivudine
Zidovudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites