Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases
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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. |
- 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
- 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 |
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| Brazil | |
| Hospital Universitário Professor Edgard Santos | |
| Salvador, Bahia, Brazil, 40110 | |
| 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 May 21, 2013