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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01472263
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Davi Tanajura Costa, Hospital Universitário Professor Edgard Santos

November 11, 2011
November 16, 2011
March 18, 2015
September 2009
September 2012   (Final data collection date for primary outcome measure)
Functional neurological capacity [ Time Frame: 60 days ]
Measure of functional neurological capacity with the Expanded Disability Status Scale (EDSS), OSAME Motor Disability Score and Ambulatorial index
Same as current
Complete list of historical versions of study NCT01472263 on Archive Site
Reduce in cytokines and chemokines [ Time Frame: 60 days ]
Measure of reduce in inflammatory cytokines (TNF alpha, IFN gamma, IL10 and IL5) and chemokines (CXCL9 and CXCL10)
Same as current
Not Provided
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Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases
Effectiveness of Pentoxifylline in Attenuating Neurological Disease Associated With HTLV-1 and Negative Modulator of Pathological Immune Response.
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.
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).
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HTLV-1
  • Tropical Spastic Paraparesis
  • Immune System Diseases
  • Physical Disability
  • Pentoxifylline
  • Drug: Pentoxifylline
    Pentoxifylline 400mg 3 times a day on a total dose o 1200mg, oral capsules
    Other Name: Trental
  • Drug: Placebo
    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.
  • Experimental: Pentoxifylline
    Intervention: Drug: Pentoxifylline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Davi Tanajura Costa, Hospital Universitário Professor Edgard Santos
Hospital Universitário Professor Edgard Santos
Not Provided
Principal Investigator: Davi Costa, MD Federal University of Bahia
Study Director: André Muniz Santos, MD, PhD Federal University of Bahia
Study Chair: Edgar M Carvalho, MD, PhD Federal University of Bahia
Hospital Universitário Professor Edgard Santos
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP