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

Keywords

ClinConnect Summary

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...

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Eligibility criteria

• 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.