Evaluation of Patients With HAM/TSP

Brief Title

Evaluation of Patients With HAM/TSP

Official Title

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

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.
    

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.
    


Study Type

Observational


Primary Outcome

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

Secondary Outcome

 Change in proviral load

Condition

HTLV-I Infection


Study Arms / Comparison Groups

 healthy volunteers
Description:  At least 18 years old and have no history of any medical illness that may confound studyresults or make participation in this protocol impossible

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

750

Start Date

April 6, 1998



Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Steven Jacobson, Ph.D., (301) 496-0519, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00001778

Organization ID

980047

Secondary IDs

98-N-0047

Responsible Party

Sponsor

Study Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)


Study Sponsor

Steven Jacobson, Ph.D., Principal Investigator, National Institute of Neurological Disorders and Stroke (NINDS)


Verification Date

April 27, 2021