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

This study has been completed.

First Received on January 4, 2006. Last Updated on June 27, 2007 History of Changes

Sponsor:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00272480

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 II Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Diseases

Drug Information available for: Zidovudine Lamivudine

U.S. FDA Resources

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

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	January 4, 2006
Last Updated:	June 27, 2007
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

HAM/TSP
HTLV-I-associated myelopathy
zidovudine
lamivudine
antiretroviral therapy

Additional relevant MeSH terms:

Bone Marrow Diseases
Spinal Cord Diseases
Paraparesis, Tropical Spastic
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Central Nervous System Infections

Zidovudine
Lamivudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012