ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Patients With HAM/TSP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00001778
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

November 3, 1999
November 4, 1999
September 20, 2018
December 31, 1997
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00001778 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Patients With HAM/TSP
Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)

Objective:

Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by monitoring clinical progression of patients longitudinally. Additionally, we will attempt to define the virological and immunological changes of HAM/TSP.

Study Population:

Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate.

Design and Outcome Measures:

A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with seroindeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes may be obtained from participants. Lumbar punctures may be performed on all participants. These samples will be used virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response, and the genetic makeup.

Objective:

Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by monitoring clinical progression of patients longitudinally. Additionally, we will attempt to define the virological and immunological changes of HAM/TSP. In addition, this protocol may be used to screen for other VIS protocols.

Study Population:

Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate.

Design and Outcome Measures:

A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with seroindeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes may be obtained from participants. Lumbar punctures may be performed on all participants. These samples will be used for virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response, and the genetic makeup.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • HTLV-I Infection
  • Tropical Spastic Paraparesis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
150
Not Provided
Not Provided
  • INCLUSION CRITERIA:
  • Participants that meet one of the following criteria:

    • Test positive for HTLV-1 infection (positive HTLV-1 ELISA followed by a positive EIA or Western blot)
    • Positive HTLV-I ELISA but a Western Blot that only partially fulfills the above criteria (sero-indeterminate)
    • Have a family member/significant other who is HTLV-1 positive, and who may have been exposed to the virus
    • Healthy volunteer

AND

-Willingness to participate in the protocol evaluations and procedures.

EXCLUSION CRITERIA:

  • Unwillingness or inability to participate in the protocol evaluations and procedures.
  • The presence of any medical, social, or psychiatric conditions that in the opinion of the investigator may affect the safety of the patients or compliance with the protocol.
  • Children under the age of 18 are excluded.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Steven Jacobson, Ph.D. (301) 496-0519 jacobsons@mail.nih.gov
United States
 
 
NCT00001778
980047
98-N-0047
Not Provided
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
Principal Investigator: Steven Jacobson, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
June 1, 2018