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

August 24, 2021 updated by: Imperial College London
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HTLV-I-associated myelopathy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo in HAM/TSP 24
Drug: Placebos
ACTIVE_COMPARATOR: Zidvoudine plus lamivudine
Zidvoudine plus lamivudine in HAM/TSP 24
Drug: Zidovudine/lamivudine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed walk
Time Frame: 6 months
Time taken to walk 13m
6 months
Osame's Motor Disability Score
Time Frame: 6 months
0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)
6 months
Pain score
Time Frame: 6 months
11 point Visual Analogue Scale 0 = no pain, 10 = worse pain
6 months
Urinary frequency
Time Frame: 6 months
Number of times passing urine during the daytime
6 months
HTLV-1 proviral load
Time Frame: 6 months
The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD25%
Time Frame: 6 months
Expression of CD25 on T-cells
6 months
HLA-DR%
Time Frame: 6 months
Expression of HLA-DR on T-cells
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Graham P Taylor, FRCP, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 1999

Primary Completion (ACTUAL)

July 30, 2002

Study Completion (ACTUAL)

July 30, 2002

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria

January 4, 2006

First Posted (ESTIMATE)

January 6, 2006

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRIDGE1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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