Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM)
HTLV-I Infection, Spinal Cord Disease, Tropical Spastic Paraparesis
About this trial
This is an interventional treatment trial for HTLV-I Infection focused on measuring HTLV-1-Associated Myelopathy, Virus, Spontaneous Proliferation
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.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)