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

NCT ID: NCT01472263

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-09-30

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pentoxifylline

Group Type: EXPERIMENTAL

Pentoxifylline

Intervention Type: DRUG

Pentoxifylline 400mg 3 times a day on a total dose o 1200mg, oral capsules

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Pentoxifylline

Pentoxifylline 400mg 3 times a day on a total dose o 1200mg, oral capsules

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Trental

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitário Professor Edgard Santos

OTHER

Sponsor Role: lead

Responsible Party

Davi Tanajura Costa

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davi Costa, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

André Muniz Santos, MD, PhD

Role: STUDY_DIRECTOR

Federal University of Bahia

Edgar M Carvalho, MD, PhD

Role: STUDY_CHAIR

Federal University of Bahia

Locations

Hospital Universitário Professor Edgard Santos

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

INCT-DT

Identifier Type: -

Identifier Source: org_study_id