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Evaluation of Patients With HAM/TSP

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ClinicalTrials.gov Identifier: NCT00001778
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief 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.


Condition or disease
HTLV-I Infection Tropical Spastic Paraparesis

Detailed Description:

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. majority of 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 viral infections. In addition, this protocol may be used to screen for other VIS protocols.

Study Population:

Individuals sero-positive for HTLV, individualas 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/tro astic paraparesis (HAM/TSP) and HTLV associated inflammatory myositis.

Design and 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 seroindeterminate 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.

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)
Actual Study Start Date : April 6, 1998


Group/Cohort
healthy volunteers
At least 18 years old and have no history of any medical illness that may confound studyresults 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



Primary Outcome Measures :
  1. To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunologicalmarkers, and viral studies. [ Time Frame: each study visit ]
    To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies.


Secondary Outcome Measures :
  1. Change in proviral load [ Time Frame: each study visit ]
    Change proviral load



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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 myositis.
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 (sero-indeterminate)
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001778


Contacts
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Contact: Steven Jacobson, Ph.D. (301) 496-0519 jacobsons@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Steven Jacobson, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00001778    
Other Study ID Numbers: 980047
98-N-0047
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 20, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Immune Response
Sero-Indeterminant
Transmission
HTLV-1
HTLV-1 Associated Myelopathy
HTLV-I
HAM/TSP
Additional relevant MeSH terms:
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Paraparesis, Tropical Spastic
HTLV-I Infections
Paraparesis
Paraparesis, Spastic
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Paresis
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Immunologic Deficiency Syndromes
Immune System Diseases