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

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

ChemIDplus related topics:

Zidovudine Lamivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

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

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

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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

Study ID Numbers:	BRIDGE1.0
First Received:	January 4, 2006
Last Updated:	June 27, 2007
ClinicalTrials.gov Identifier:	NCT00272480
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

HAM/TSP

HTLV-I-associated myelopathy

zidovudine

lamivudine

antiretroviral therapy

Study placed in the following topic categories:

Spinal Cord Diseases

Paraparesis, Tropical Spastic

Central Nervous System Diseases

Zidovudine

Lamivudine

Immunologic Deficiency Syndromes

Virus Diseases

Central Nervous System Infections

Myelitis

HTLV-I Infections

Paraparesis

Retroviridae Infections

Tropical Spastic Paraparesis

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Central Nervous System Viral Diseases

Enzyme Inhibitors

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Deltaretrovirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008

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