Clinical Trial: Raltegravir for HAM/TSP

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: Pilot Study of Raltegravir, an Integrase Inhibitor, in Human T-Cell Lymphotrophic Virus-1(HTLV-1) Associated Myelopathy, Tropical Spastic Paraparesis (HAM/TSP)

Brief Summary:

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.