Evaluating patients with HTLV-I infection and tropical spastic paraparesis
Official title: Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)
Run by National Institutes of Health Clinical Center (CC) · NCT00001778 · Data updated 2026-11-12
This study is trying to understand how HTLV-I infection affects people with tropical spastic paraparesis over time by tracking their symptoms and health changes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | April 6, 1998 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT00001778 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with HAM/TSP, asymptomatic seropositive individuals, and those with indeterminate HTLV-1 serology.
✕Probably not a fit
Patients under the age of 18 or those with medical conditions that may affect their safety or compliance with the study will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to investigate the natural history of human T-lymphotropic virus type-I-associated myelopathy/tropical spastic paraparesis (HAM/TSP) by conducting longitudinal assessments of patients diagnosed with the condition. It will monitor clinical progression and analyze virological and immunological changes over time. Eligible participants include those with confirmed HTLV-I infection, seroindeterminate individuals, and healthy volunteers. The study will involve periodic testing and evaluations to gather comprehensive data on the disease's progression.
Why it matters
Potential benefit: If successful, this study could enhance understanding of HAM/TSP and lead to improved management strategies for affected patients.
How similar studies have gone: While there is existing literature on HTLV-1, this study's longitudinal approach to understanding HAM/TSP is relatively novel and may provide new insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: 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. 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. * Patients/healthy volunteers under the age of 18 are excluded.
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Steven Jacobson, Ph.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Christopher Y Itoh, M.D.
- Email: christopher.itoh@nih.gov
- Phone: (301) 496-3825
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Dolutegravir with or without Tenofovir for HTLV-1 infection
This phase 2b trial tests whether dolutegravir alone or with tenofovir can lower HTLV-1 proviral load and improve related symptoms in adults with HTLV-1 infection.
-
Combining lenalidomide with standard chemotherapy for adult T-cell leukemia-lymphoma
This study is testing if adding lenalidomide to standard chemotherapy can help adults with T-cell leukemia-lymphoma feel better and live longer.
-
Targeting the plantaris tendon during surgery to correct ankle equinus in children
This trial tests whether cutting the small plantaris tendon, together with standard calf-lengthening surgery, helps children aged 4–17 with ankle equinus walk and use their feet better.
-
Intensive training program for patients with hereditary spastic paraparesis
This study tests if a 6-week intensive physical rehab program can help people with hereditary spastic paraparesis walk faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.