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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

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.

Condition or disease Intervention/treatment Phase
HTLV-1 Tropical Spastic Paraparesis Immune System Diseases Physical Disability Pentoxifylline Drug: Pentoxifylline Drug: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : September 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01472263

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

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Responsible Party: Davi Tanajura Costa, MD, Hospital Universitário Professor Edgard Santos Identifier: NCT01472263     History of Changes
Other Study ID Numbers: INCT-DT
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
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Muscle Spasticity
Immune System Diseases
Paraparesis, Spastic
Paraparesis, Tropical Spastic
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs