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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00272480
First Posted: January 6, 2006
Last Update Posted: May 28, 2015
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.
Information provided by:
Imperial College London
  Purpose
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 Intervention Phase
HTLV-I-associated Myelopathy Drug: Zidovudine/lamivudine Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Clinical:
  • Timed walk
  • Pain score
  • Urinary frequency
  • Bowel function
  • Disability scale

Secondary Outcome Measures:
  • Viral load
  • Markers of inflammation
  • Markers of proliferation

Estimated Enrollment: 24
Study Start Date: November 1999
Estimated Study Completion Date: November 2001
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
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

HTLV-I-associated myelopathy -

Exclusion Criteria:

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

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

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

ClinicalTrials.gov Identifier: NCT00272480     History of Changes
Other Study ID Numbers: BRIDGE1.0
First Submitted: January 4, 2006
First Posted: January 6, 2006
Last Update Posted: May 28, 2015
Last Verified: January 2006

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

Additional relevant MeSH terms:
Paraparesis, Tropical Spastic
Spinal Cord Diseases
Bone Marrow Diseases
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