Protocol Details
Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)
This study is currently recruiting participants.
Summary
Number | 98-N-0047 |
Sponsoring Institute | National Institute of Neurological Disorders and Stroke (NINDS) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years |
Referral Letter Required | No |
Population Exclusion(s) | Children |
Keywords | Immune Response;
Sero-Indeterminant;
Transmission;
HTLV-1;
HTLV-1 Associated Myelopathy;
Natural History |
Recruitment Keyword(s) | HTLV-I;
HAM/TSP |
Condition(s) | HTLV-I Infection;
Tropical Spastic Paraparesis |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Institute of Neurological Disorders and Stroke |
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.
Eligibility
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 (seroindeterminate)
-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.
Citations:
Gessain A, Barin F, Vernant JC, Gout O, Maurs L, Calender A, de The G. Related Articles, Links Antibodies to human T-lymphotropic virus type-I in patients with tropical spastic paraparesis. Lancet. 1985 Aug 24; 2(8452): 407-10. Osame M, Matsumoto M, Usuku K, Izumo S, Ijichi N, Amitani H,Tara M, Igata A. Related Articles, Links Chronic progressive myelopathy associated with elevated antibodies to human T-lymphotropic virus type I and adult T-cell leukemialike cells. Ann Neurol. 1987 Feb; 21(2): 117-22. Iwasaki Y. Related Articles, Links Pathology of chronic myelopathy associated with HTLV-I infection (HAM/TSP). J Neurol Sci. 1990 Apr; 96(1): 103-23.
Contacts:
Clinical Trials Number:
NCT00001778Protocol Details
Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)
This study is currently recruiting participants.
Summary
Number | 98-N-0047 |
Sponsoring Institute | National Institute of Neurological Disorders and Stroke (NINDS) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years |
Referral Letter Required | No |
Population Exclusion(s) | Children |
Keywords | Immune Response;
Sero-Indeterminant;
Transmission;
HTLV-1;
HTLV-1 Associated Myelopathy;
Natural History |
Recruitment Keyword(s) | HTLV-I;
HAM/TSP |
Condition(s) | HTLV-I Infection;
Tropical Spastic Paraparesis |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Institute of Neurological Disorders and Stroke |
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.
Eligibility
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 (seroindeterminate)
-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.
Citations:
Gessain A, Barin F, Vernant JC, Gout O, Maurs L, Calender A, de The G. Related Articles, Links Antibodies to human T-lymphotropic virus type-I in patients with tropical spastic paraparesis. Lancet. 1985 Aug 24; 2(8452): 407-10. Osame M, Matsumoto M, Usuku K, Izumo S, Ijichi N, Amitani H,Tara M, Igata A. Related Articles, Links Chronic progressive myelopathy associated with elevated antibodies to human T-lymphotropic virus type I and adult T-cell leukemialike cells. Ann Neurol. 1987 Feb; 21(2): 117-22. Iwasaki Y. Related Articles, Links Pathology of chronic myelopathy associated with HTLV-I infection (HAM/TSP). J Neurol Sci. 1990 Apr; 96(1): 103-23.
Contacts:
Clinical Trials Number:
NCT00001778