Background:
- Human T-cell lymphotropic virus type 1 associated myelopathy/tropical spastic paraparesis
(HAM/TSP) is an infection of the spinal cord. The infection is caused by a virus that has
been known to cause cancers like leukemia and lymphoma. It causes a weakening of the legs.
Researchers want to see if raltegravir, a drug for treating human immunodeficiency virus
(HIV), can be used to treat HAM/TSP. They will see if the drug can reduce the amount of virus
in the blood of people with HAM/TSP.
Objectives:
- To see if raltegravir can reduce the viral load of people with HAM/TSP.
Eligibility:
- Individuals at least 18 years of age who have HAM/TSP.
Design:
- Participants will be screened with a physical exam and medical history. Blood samples
will be collected. Imaging studies will be performed. A lumbar puncture will also be
taken.
- Participants will take the study drug twice a day for 6 months. They will note each dose
in a study diary, as well as any side effects.
- At the 6-month visit, participants will stop taking the study drug. They will have a
physical exam and blood samples, as well as other tests.
- Participants will have two further exams 9 months and 15 months after starting the study
drug. They will have a physical exam and blood samples, as well as other tests.
Phase:
Early Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)