Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM)

NCT00001785 | Completed Phase 2

• 2 other identifiers: 98016098-N-0160
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HTLV-I Infection; Spinal Cord Disease; Tropical Spastic Paraparesis

Keywords

HTLV-1-Associated Myelopathy; Virus; Spontaneous Proliferation

Interventions

Recombinant human interferon beta-1a DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Elovaara I, Koenig S, Brewah AY, Woods RM, Lehky T, Jacobson S. High human T cell lymphotropic virus type 1 (HTLV-1)-specific precursor cytotoxic T lymphocyte frequencies in patients with HTLV-1-associated neurological disease. J Exp Med. 1993 Jun 1;177(6):1567-73. doi: 10.1084/jem.177.6.1567.

  PMID: 8496677 BACKGROUND

• Hollsberg P, Hafler DA. Seminars in medicine of the Beth Israel Hospital, Boston. Pathogenesis of diseases induced by human lymphotropic virus type I infection. N Engl J Med. 1993 Apr 22;328(16):1173-82. doi: 10.1056/NEJM199304223281608. No abstract available.

  PMID: 8455685 BACKGROUND

• Gessain A, Gout O. Chronic myelopathy associated with human T-lymphotropic virus type I (HTLV-I). Ann Intern Med. 1992 Dec 1;117(11):933-46. doi: 10.7326/0003-4819-117-11-933.

  PMID: 1443956 BACKGROUND

MeSH Terms

Conditions

HTLV-I Infections; Spinal Cord Diseases; Paraparesis, Tropical Spastic; Virus Diseases

Condition Hierarchy (Ancestors)

Deltaretrovirus Infections; Retroviridae Infections; RNA Virus Infections; Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Central Nervous System Diseases; Nervous System Diseases; Myelitis; Central Nervous System Infections; Neuroinflammatory Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: September 1, 1998
• Study Completion: September 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-09

Locations

US (1)