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NCT01867320 · ClinicalTrials.gov registry record · Early Phase 1
Raltegravir for HAM/TSP
A Early Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
NCT01867320 is a Early Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 19 participants.
The verdict
NCT01867320, a Early Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 19 participants
- Enrollment target
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.
Interventions
- DRUG Raltegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-09-05 |
| Est. Completion | 2018-09-25 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01867320
The ClinicalTrials.gov registry entry for NCT01867320 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Raltegravir is the first listed.
NCT01867320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01867320 about?
NCT01867320 is a clinical study titled "Raltegravir for HAM/TSP". 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 w...
What is the current status of trial NCT01867320?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2013-09-05. Estimated completion is 2018-09-25.
What interventions are being tested in trial NCT01867320?
The interventions under investigation include: Raltegravir (DRUG).
Who is sponsoring clinical trial NCT01867320?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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