Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases
Condition: HTLV-1; Tropical Spastic Paraparesis; Immune System Diseases; Physical Disability; Pentoxifylline
MeSH terms: Paraparesis, Tropical Spastic; Muscle Spasticity; Paraparesis; Paraparesis, Spastic; Immune System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study the investigators are going to evaluate the efficacy pentoxifyline in HTLV-1
      patients with neurological diseases: HAM/TSP or neurogenic bladder. In some laboratory
      experiments the investigators observed that this drug had the capacity to reduce the immune
      response in HTLV-1 infected cells. Since the exacerbated immune response is know to cause
      neurological disease in patients with HTLV-1 the investigators hope that pentoxifyline can
      alleviate symptoms and delay the progress of HAM/TSP in patients.
    

Detailed description: 
      The human T-lymphotropic virus type 1 (HTLV-1) infects 20 million individuals worldwide and
      is the causative agent of HTLV associated myelopathy/ tropical spastic paraparesis (HAM/TSP).
      Although only 5% of HTLV-infected individuals will develop HAM/TSP, the investigatorts have
      observed that about 30% have neurological complaints and/or neurogenic bladder associated
      with HTLV-1. The immunopathogenesis of those diseases is related to the exaggerated immune
      response with high production of cytokines and induced neurological injury. So far there is
      not any effective drug against HTLV-1 and modulation of the immune response can help to
      alleviate the clinical manifestations of those patients and prevent the progression of
      symptoms. The preliminary data show that pentoxifylline has ability to decrease production of
      TNF-α and IFN-γ in patients with HTLV-1 infection and patients with HAM/TSP. The proposal
      entitled "Evaluation of the efficacy of pentoxifylline in attenuating the neurological
      disease associated with HTLV-1 and negatively modulate the immune pathological response"
      extends the previous studies in order to determine the ability of pentoxifylline in modulate
      the immune response and modify the course of the clinical manifestations in patients infected
      with HTLV-1. The influence on the immune response in the expression of disease will be
      determined in a therapeutic trial with two groups of patients: 1) patients with neurogenic
      bladder associated with HTLV-1, 2) patients with HAM/TSP. Primary end point is clinical and
      neurological exam and secondary end point are measure of proinflammatory cytokines (TNF-α,
      IFN-γ, IL-1 and IL-6) and chemokines that attract T cells to sites of inflammation (CXCL9 and
      CXCL10).
    

Intervention name(s): Pentoxifylline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pentoxifylline 400mg 3 times a day on a total dose o 1200mg, oral capsules; Placebo capsules 3 times a day. The capsules have the same shape, color and form as the treatment group, and are identified by envelope numbers.
Other intervention name(s): Trental
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HTLV-1; tropical spastic paraparesis; Immune System Diseases; Physical disability; pentoxifylline