Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001778
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
1999-11-03
Brief Title:
Evaluation of Patients With HAMTSP
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy HAMTSP
Status:
RECRUITING
Status Verified Date:
2024-06-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective
Human T-lymphotropic virus type-I-associated myelopathy tropical spastic paraparesis HAMTSP 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 HAMTSP by monitoring clinical progression of patients longitudinally Additionally we will attempt to define the virological and immunological changes of HAMTSP
Study Population
Patients with HAMTSP 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 HAMTSP 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
Human T-lymphotropic virus type-I-associated myelopathy tropical spastic paraparesis HAMTSP 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 HAMTSP by monitoring clinical progression of patients longitudinally Additionally we will attempt to define the virological and immunological changes of HAMTSP
Study Population
Patients with HAMTSP 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 HAMTSP 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 HAMTSP 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 myelopathytropical spastic paraparesis HAMTSP 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
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 HAMTSP 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 myelopathytropical spastic paraparesis HAMTSP 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-N-0047 | None | None | None |