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Raltegravir for HAM/TSP

NCT01867320 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-03-30

No results posted yet for this study

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.

Conditions

  • HTLV-I Infection

Interventions

DRUG

Raltegravir

Raltegravir at 400mg by mouth twice daily in an initial 6 months treatment phase, followed by an additional 9 months post treatment phase.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Steven Jacobson, Ph.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-05
Primary Completion
2018-09-25
Completion
2018-09-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867320 on ClinicalTrials.gov