Evaluation of Patients With HAM/TSP

ConditionsHTLV-I Infection Tropical Spastic Paraparesis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-120

SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

About this trial

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.

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Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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 myositis.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

750 Participants

are grouped into 3 trial groups

Group A: healthy volunteers

Group B: individuals seropositive for HTLV

Group C: individuals with indeterminate HTLV sero-status

Trial outcomes

Primary outcomes

To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies.

Time frame

each study visit

Secondary outcomes

Change in proviral load

Change proviral load

Time frame

each study visit

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Neurological Disorders and Stroke (NINDS)

Lead sponsor

Source ClinicalTrials.gov

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