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

This study has been completed.
Information provided by (Responsible Party):
Davi Tanajura Costa, Hospital Universitário Professor Edgard Santos Identifier:
First received: November 11, 2011
Last updated: March 17, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Tropical Spastic Paraparesis
Immune System Diseases
Physical Disability
Drug: Pentoxifylline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Pentoxifylline in Attenuating Neurological Disease Associated With HTLV-1 and Negative Modulator of Pathological Immune Response.

Resource links provided by NLM:

Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:
  • Functional neurological capacity [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Measure of functional neurological capacity with the Expanded Disability Status Scale (EDSS), OSAME Motor Disability Score and Ambulatorial index

Secondary Outcome Measures:
  • Reduce in cytokines and chemokines [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Measure of reduce in inflammatory cytokines (TNF alpha, IFN gamma, IL10 and IL5) and chemokines (CXCL9 and CXCL10)

Enrollment: 48
Study Start Date: September 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pentoxifylline Drug: Pentoxifylline
Pentoxifylline 400mg 3 times a day on a total dose o 1200mg, oral capsules
Other Name: Trental
Placebo Comparator: Placebo 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.

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).

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01472263

Hospital Universitário Professor Edgard Santos
Salvador, Bahia, Brazil, 40110
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
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
  More Information

Responsible Party: Davi Tanajura Costa, MD, Hospital Universitário Professor Edgard Santos Identifier: NCT01472263     History of Changes
Other Study ID Numbers: INCT-DT 
Study First Received: November 11, 2011
Last Updated: March 17, 2015
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital Universitário Professor Edgard Santos:
tropical spastic paraparesis
Immune System Diseases
Physical disability

Additional relevant MeSH terms:
Immune System Diseases
Paraparesis, Spastic
Paraparesis, Tropical Spastic
Central Nervous System Diseases
Central Nervous System Infections
Deltaretrovirus Infections
HTLV-I Infections
Nervous System Diseases
Neurologic Manifestations
RNA Virus Infections
Retroviridae Infections
Signs and Symptoms
Spinal Cord Diseases
Virus Diseases
Enzyme Inhibitors
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Vasodilator Agents processed this record on May 30, 2016