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

NCT01472263 | Completed Phase 3 DMC

• 1 other identifier: INCT-DT
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HTLV-1; tropical spastic paraparesis; Immune System Diseases; Physical disability; pentoxifylline

Outcome Measures

Primary Outcomes (1)

• Functional neurological capacity

  Measure of functional neurological capacity with the Expanded Disability Status Scale (EDSS), OSAME Motor Disability Score and Ambulatorial index

  60 days

Secondary Outcomes (1)

• Reduce in cytokines and chemokines

  60 days

Study Arms (2)

Pentoxifylline

EXPERIMENTAL

Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pentoxifylline DRUG

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

Also known as: Trental

Pentoxifylline

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Neurological diseases with functional limitations.
• Co-infection with Hepatitis B or C, Syphilis, Chagas Disease or HIV
• Use of immunossupressive drugs
• Immune disease
• Pregnancy

Sponsors & Collaborators

• Hospital Universitário Professor Edgard Santos: lead

Study Sites (1)

Hospital Universitário Professor Edgard Santos

Salvador, Estado de Bahia, 40110, Brazil

Location

MeSH Terms

Conditions

Paraparesis, Tropical Spastic; Immune System Diseases

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; HTLV-I Infections; Deltaretrovirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Davi Costa, MD

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

• André Muniz Santos, MD, PhD

  Federal University of Bahia

  STUDY DIRECTOR

• Edgar M Carvalho, MD, PhD

  Federal University of Bahia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 16, 2011
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

BR (1)