The HAM Infliximab Study

Overview

An open-label, non-randomised, uncontrolled, proof-of-concept study of eight patients with 'definite' HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Eligible patients will have either early disease (of less than 2 years duration) or progressive disease (with observed clinical deterioration during the preceding 3 months. Following 2 baseline assessments including Magnetic Resonance Imaging (MRI) of the spinal cord and a lumbar puncture for examination of the fluid around the brain (CSF) participants will be treated with a total of 7 infusions of the anti-TNF-alpha antibody infliximab over a period of 48 weeks. After the last on therapy assessment at 48 weeks participants will be followed up for a further 24 weeks. Study assessments will be clinical, virological, immunological and radiological. MRIs of the spinal cord will be obtained at weeks 12 and 72. CSF will be examined, on therapy, at week 12.

Full Title of Study: “An Open, Non-randomised Pilot Study of Anti-TNF-alpha Therapy in Early or Progressing HAM/TSP”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2011

Interventions

  • Drug: Infliximab
    • Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study

Arms, Groups and Cohorts

  • Experimental: Infliximab
    • Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of clinical failure
    • Time Frame: 48 weeks

Secondary Measures

  • Change in timed 10m walk
    • Time Frame: 12, 24, 48 and 72 weeks
  • Clinical Safety
    • Time Frame: 48 weeks
  • HTLV-I viral load in CSF
    • Time Frame: 12 weeks
  • HTLV-I viral load in peripheral blood
    • Time Frame: 12, 24, 48 and 72 weeks
  • % CD4+ T- lymphocytes expressing CD25
    • Time Frame: 24, 48 and 72 hours

Participating in This Clinical Trial

Inclusion Criteria

  • Are able to give informed consent – Are 16 years or older – Have 'definite' HAM/TSP according to the criteria of "Definite HAM/TSP" agreed in Belem 200361 – Have early or progressing disease as defined here: – "Early HAM/TSP": Patients must have motor disability (minimum of stiffness or weakness) for less than 2 years. (Bladder symptoms if the original and only presenting symptoms as assessed by history are not included) – "Progressing HAM/TSP" – New or worsening motor symptoms in a patient with definite HAM of > 2 years duration within the last 3 months Exclusion Criteria:

  • Hepatitis B or hepatitis C infection – HIV infection – Overt sepsis, abscesses or opportunistic infections – Active TB (untreated or on treatment) – Strongyloides stercoralis (untreated) – Known hypersensitivity to inflixmab, other murine proteins or to any of the excipients – Malignancy – Moderate or severe heart failure (NYHA class III/IV) – Pregnancy or breastfeeding – Unhealed surgical wounds – Planned impending surgery – treatment would be withheld for 2-4 weeks prior to major surgery and started/restarted post-operatively if no evidence of infection and wound healing is satisfactory – Current immunosuppressive or immunomodulatory therapy

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Imperial College London
  • Collaborator
    • Medical Research Council
  • Provider of Information About this Clinical Study
    • Principal Investigator: Graham Taylor, Reader in Communicable Diseases – Imperial College London
  • Overall Official(s)
    • Graham P Taylor, MD, Principal Investigator, Imperial College London

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