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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00272480
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : May 28, 2015
Information provided by:
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 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)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
Study Start Date : November 1999
Study Completion Date : November 2001

Primary Outcome Measures :
  1. Clinical:
  2. Timed walk
  3. Pain score
  4. Urinary frequency
  5. Bowel function
  6. Disability scale

Secondary Outcome Measures :
  1. Viral load
  2. Markers of inflammation
  3. Markers of proliferation

Information from the National Library of Medicine

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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

Inclusion Criteria:

HTLV-I-associated myelopathy -

Exclusion Criteria:

prior exposure to zidovudine or lamvudine 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 identifier (NCT number): NCT00272480

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

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

Layout table for additonal information Identifier: NCT00272480     History of Changes
Other Study ID Numbers: BRIDGE1.0
First Posted: January 6, 2006    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: January 2006

Keywords provided by Imperial College London:
HTLV-I-associated myelopathy
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
Central Nervous System Infections
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