Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases

Brief Title

Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases

Official Title

Effectiveness of Pentoxifylline in Attenuating Neurological Disease Associated With HTLV-1 and Negative Modulator of Pathological Immune Response.

Brief 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).
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Functional neurological capacity

Secondary Outcome

 Reduce in cytokines and chemokines

Condition

HTLV-1

Intervention

Pentoxifylline

Study Arms / Comparison Groups

 Pentoxifylline
Description:  

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

Drug

Estimated Enrollment

48

Start Date

September 2009

Completion Date

September 2012

Primary Completion Date

September 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 18 and ≤ 80 years;

          -  Confirmed HTLV-1 infection with Western Blot analysis;

          -  HAM/TSP diagnosed patients according to the WHO

          -  Patients with HTLV-1 and neurogenic bladder diagnosed by clinical and urodynamic study

          -  Disease duration < 5 years

        Exclusion Criteria:

          -  Neurological diseases with functional limitations.

          -  Co-infection with Hepatitis B or C, Syphilis, Chagas Disease or HIV

          -  Use of immunossupressive drugs

          -  Immune disease

          -  Pregnancy
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Davi Costa, MD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01472263

Organization ID

INCT-DT


Responsible Party

Principal Investigator

Study Sponsor

Hospital Universitário Professor Edgard Santos


Study Sponsor

Davi Costa, MD, Principal Investigator, Federal University of Bahia


Verification Date

March 2015