Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: t
View:

⁃ Participants that meet one of the following criteria:

• Test positive for HTLV infection (positive HTLV-1 ELISA followed by a positive Western blot)

• Positive HTLV ELISA but a Western Blot that only partially fulfills the above criteria (seroindeterminate)

• Have a family member/significant other who is HTLV positive, and may have been exposed to the virus

• Healthy volunteer AND

• Willingness to participate in the protocol evaluations and procedures.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Daniel S Reich, M.D.
reichds@ninds.nih.gov
(301) 496-1801
Backup
Steven Jacobson, Ph.D.
jacobsons@ninds.nih.gov
(301) 496-0519
Time Frame
Start Date: 1998-04-06
Participants
Target number of participants: 750
Treatments
healthy volunteers
At least 18 years old and have no history of any medical illness that may confound study results or make participation in this protocol impossible
individuals seropositive for HTLV
Positive HTLV-1 ELISA followed by a positive Western Blot
individuals with indeterminate HTLV sero-status
Positive HTLV ELISA but a Western Blot that only partially fulfills criteria
Sponsors
Leads: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov

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