Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Early Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure is HTLV-1 proviral load in the peripheral blood mononuclear cells (PBMCs) measured by Taqman at month 6 compared to pretreatment value.
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 |
What the finished NCT01867320 record still lists
NCT01867320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which Raltegravir is the first listed.
NCT01867320 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01867320's enrollment target sits among peer trials
19 1292nd of 2000 higher than 686 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03207464 · 19 participants · Phase 1
Molecular Imaging of NET Using [C-11]MRB-PET in MS
- NCT04318717 · 19 participants · Phase 2
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
- NCT05103904 · 19 participants · Phase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
- NCT05607407 · 19 participants · Phase 2
Methimazole in Patients With Progressive Glioblastoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI