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Completed

NCT Number: NCT00272480

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

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

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Key information

Conditions

HTLV-I-associated Myelopathy Central Nervous System Diseases Central Nervous System Infections Deltaretrovirus Infections HTLV-I Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Paraparesis, Tropical Spastic RNA Virus Infections Retroviridae Infections Spinal Cord Diseases Virus Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Imperial College

London, W2 1PG, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HTLV-I-associated myelopathy

Exclusion criteria

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

Treatment and study plan

Zidovudine/Lamivudine

Drug

Placebos

Drug

Primary outcomes

  1. Timed walk

    Time frame: 6 months

    Time taken to walk 13m

  2. Osame's Motor Disability Score

    Time frame: 6 months

    0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)

  3. Pain score

    Time frame: 6 months

    11 point Visual Analogue Scale 0 = no pain, 10 = worse pain

  4. Urinary frequency

    Time frame: 6 months

    Number of times passing urine during the daytime

  5. HTLV-1 proviral load

    Time frame: 6 months

    The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells

Secondary outcomes

  1. CD25%

    Time frame: 6 months

    Expression of CD25 on T-cells

  2. HLA-DR%

    Time frame: 6 months

    Expression of HLA-DR on T-cells

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
1999
Primary completion
2002
Study completion
2002
First posted
Jan 6, 2006
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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