Evaluation of Patients With HAM/TSP

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 inHTLV
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.

- 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.