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

Tracking Information

First Received Date ^ICMJE

January 4, 2006

Last Updated Date

June 27, 2007

Start Date ^ICMJE

November 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Clinical:
Timed walk
Pain score
Urinary frequency
Bowel function
Disability scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00272480 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Viral load
Markers of inflammation
Markers of proliferation

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

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

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Crossover Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

HTLV-I-Associated Myelopathy

Intervention ^ICMJE

Drug: Zidovudine/lamivudine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2001

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HTLV-I-associated myelopathy -

Exclusion Criteria:

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

Gender

Both

Ages

16 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00272480

Responsible Party

Study ID Numbers ^ICMJE

BRIDGE1.0

Study Sponsor ^ICMJE

Imperial College London

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Graham P Taylor, FRCP

Imperial College London

Information Provided By

Imperial College London

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP