Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM)
Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · Nov 3, 1999
Current as of December 07, 2023
HTLV-1 has been linked to a chronic, slowly progressive neurologic condition termed HTLV-1 associated spastic paraparesis or tropical spastic paraparesis (HAM/TSP) which affects about 1% of the infected individuals. The disease is thought to be due to a T cell viral induced immunopathological process. A high frequency of HTLV-1 specific CD8 T cells are found in patients with HAM/TSP. The immune system of patients infected with HTLV-1 appears to be dysregulated, and increased spontaneous T cell proliferation can be demonstrated in vitro. This is in part due to continuous antigenic stimulatio...
- INCLUSION CRITERIA:
- patients entering this study will:
- be at least 16 years old;
- meet diagnostic criteria for HAM/TSP as defined by the WHO and current literature;
- have progression of the clinical symptoms during the past 12 months;
- have an EDSS of less than or equal to 7;
- have spontaneous in vitro lymphoproliferation;
- able to provide written informed consent;
- able to comply with protocol requirements;
- if a females, be not of a child bearing potential or if of child bearing potential documented to be non-pregnant by urine pregnancy test with adequate counseling and contraception.
- EXCLUSION CRITERIA:
- Patients entering this study will not:
- be pregnant or lactating;
- be HIV, HCV, or hepatitis B surface antigen positive;
- have a significant medical condition that in the opinion of the investigator would compromise the safety of the patient;
- have a history of suicidal ideations and no major depressive event (DSM-IV) within 3 months of enrollment;
- have used an investigational medication or steroids within 90 days of the enrollment visit;
- have a history of an allergic reaction to albumin;
- have metallic fragments, ferromagnetic surgical clips, and implanted electronic devices (cardiac pace makers, vagal nerve stimulators);
- drug abuse.
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States
All reviews come from applied patients