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Protocol Number:
98-N-0047
- Title:
Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)
- Number:
98-N-0047
- 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 with emphasis on defining its virological and immunological changes with respect to clinical progression.
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 serodeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes will be obtained from participants. Lumbar punctures may be performed on individuals with HAM/TSP. 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.
- Sponsoring Institute:
-
National Institute of Neurological Disorders and Stroke (NINDS)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
Yes
- Population Exclusion(s):
Children
- Eligibility Criteria:
INCLUSION CRITERIA:
- Positive HTLV-I EIA or Western blot positive for HTLV-I bands.
- 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.
- Children under the age of 18 are excluded.
- Special Instructions:
Currently Not Provided
- Keywords:
-
Immune Response
-
Sero-Indeterminant
-
Transmission
-
Tropical Spastic Paraparesis
-
Viral Load
- 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
- Contact(s):
-
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793
Electronic Mail:prpl@mail.cc.nih.gov
- Citation(s):
-
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.
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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.
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