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Immuno-Virological Study of HTLV-1 Associated Myelopathy in Sero-Positive Individuals

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Study Aim

This study aims to observe and characterize the clinical, imaging, immunological, and viral features in individuals who are sero-positive for HTLV-1 associated myelopathy.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Neuroinflammatory Diseases+12

+ Central Nervous System Diseases

+ Central Nervous System Infections

From 18 to 120 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 1998
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Study ContactDaniel S Reich, M.D.More contacts
Last updated: July 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 6, 1998

Actual date on which the first participant was enrolled.

Objective Human T lymphotropic virus type 1 (HTLV-1) was first discovered in the search for retroviruses causing cancer in 1981. Shortly afterwards, HTLV-2 was also isolated. Although HTLV-1 and HTLV-2 share similar genome structure, routes of transmission, and replication pattern, they differ in epidemiology and disease associations. 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. Recently, a large body of literature supports other inflammatory manifestations, some neurological such as myositis, due to HTLV-1 infection. Studies of HLTV-2 clinical manifestations have largely been confounded by concomitant HIV-1 infection or IV drug abuse making the establishment of clear relationship with other manifestations such as neurological disease difficult. Most patients infected with HTLV remain asymptomatic throughout their lifetime. The purpose of this protocol is to study the natural history of HTLV infection by monitoring participants longitudinally. Additionally, we will attempt to define the virological and immunological changes of these viral infections. In addition, this protocol may be used to screen for other VIS protocols. Study Population Individuals sero-positive for HTLV, individuals with indeterminate HTLV sero-status, and healthy volunteers are eligible to participate in this protocol. Some individuals sero-positive for HTLV may have associated diseases including but not limited to HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) and HTLV associated inflammatory disorders. Design \& Outcome Measures A longitudinal assessment of clinical, virological and immunological progression in HTLV related disease will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with sero-indeterminate HTLV serology and healthy 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.

NCT00001778
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Study ContactDaniel S Reich, M.D.More contacts
Last updated: July 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

750 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neuroinflammatory DiseasesCentral Nervous System DiseasesCentral Nervous System InfectionsDeltaretrovirus InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMyelitisNervous System DiseasesRetroviridae InfectionsRNA Virus InfectionsSpinal Cord DiseasesVirus DiseasesHTLV-I InfectionsParaparesis, Tropical Spastic

Criteria

4 inclusion criteria required to participate
Have a family member/significant other who is HTLV positive, and may have been exposed to the virus

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

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

Willingness to participate in the protocol evaluations and procedures

3 exclusion criteria prevent from participating
Patients/healthy volunteers under the age of 18 are excluded

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

Unwillingness or inability to participate in the protocol evaluations and procedures

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
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One Study Center