Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM)
Status:
Completed
Trial end date:
2004-09-01
Target enrollment:
Participant gender:
Summary
HTLV stands for human T cell leukemia virus. HTLV-1 is a virus that attacks specific kinds of
white blood cells called T cells. T cells are part of the natural defense system of the body.
HTLV-1 has been associated with leukemia and lymphoma. In addition, approximately 1% of all
patients infected with HTLV-1 develops a condition known as HTLV-1 associated myelopathy
(HAM) / tropical spastic paraparesis (TSP).
Currently there is no clearly defined, effective treatment for patients with HAM/TSP.
Steroids have been used as therapy but have only been able to provide temporary relief of
symptoms. Human interferon is a small protein released from different kinds of cells in the
body. Interferon has been known to have antiviral and immunological effects and has been used
to treat hepatitis and multiple sclerosis. Interferon Beta is released from cells called
fibroblasts. These cells play a role in the production of connective tissue.
The purpose of this study is to evaluate the possible role of recombinant interferon beta
(Avonex) in treatment of HAM/TSP. The study is broken into three phases, a pre-treatment
phase, a treatment phase, and a post-treatment phase. The total duration of the study will be
44 weeks.
Patients participating in this study will receive injections of Avonex 1 to 2 times a week.
Throughout the study patients will regularly submit blood samples and undergo diagnostic
tests such as MRI and measures of somatosensory evoked potentials.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)