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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Hospital Universitário Professor Edgard Santos.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Davi Tanajura Costa, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT01472263
First received: November 11, 2011
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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
HTLV-1
Tropical Spastic Paraparesis
Immune System Diseases
Physical Disability
Pentoxifylline
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)


Estimated Enrollment: 48
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated 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.
Other Name: Placebo

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472263

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

No publications provided

Responsible Party: Davi Tanajura Costa, MD, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier: NCT01472263     History of Changes
Other Study ID Numbers: INCT-DT
Study First Received: November 11, 2011
Last Updated: November 16, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital Universitário Professor Edgard Santos:
HTLV-1
tropical spastic paraparesis
Immune System Diseases
Physical disability
pentoxifylline

Additional relevant MeSH terms:
Immune System Diseases
Paraparesis, Tropical Spastic
Paraparesis, Spastic
Paraparesis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Paresis
Neurologic Manifestations
Signs and Symptoms
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on August 28, 2014