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

NCT01472263 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-03-18

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Pentoxifylline

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

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.

Sponsors & Collaborators

  • Hospital Universitário Professor Edgard Santos

    lead OTHER

Principal Investigators

  • Davi Costa, MD · Federal University of Bahia

  • André Muniz Santos, MD, PhD · Federal University of Bahia

  • Edgar M Carvalho, MD, PhD · Federal University of Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01472263 on ClinicalTrials.gov