Status:
COMPLETED
Raltegravir for HAM/TSP
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
HTLV-I Infection
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
Detailed Description
Objective: In this pilot study, we wish to determine the effects of Raltegravir, a clinically approved HIV-1 integrase inhibitor, on HTLV-1 proviral load (PVL) in patients with HTLV-1 associated myel...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 18 years or older
- Diagnosis of HAM/TSP as defined by WHO criteria, including a positive HTLV-1 EIA and confirmatory Western Blot.
- Patient must be willing and able to comply with all the aspects of trial design and follow-up.
- Patients must be able to provide informed consent
- If able to become pregnant or to father a child, agreeing to commit to the use of a reliable/accepted method of birth control (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation, or vasectomy) for the duration of treatment arm of the study
- EXCLUSION CRITERIA:
- Alternative diagnoses that can explain neurological disability
- Clinically significant medical disorders that, in the judgment of the investigators might expose the patient to undue risk of harm confound study outcomes or prevent the patient from completing the study. Examples of such conditions include but are not limited to poorly controlled cardiopulmonary conditions such as congestive heart failure, asthma or uncontrolled hypertension.
- Patient has received immunomodulatory/immunosuppressive therapy (including steroids) in the preceding 6 months.
- Patient with known myopathy or risk factors for CK elevation including being on other drugs known to cause myopathy or rhabdomyolysis.
- Pregnant or lactating women.
- Patient has received other investigational drugs within 6 months before enrollment
- Positive serological evidence of HIV, HTLV-II, Hepatitis B or C.
- Abnormal screening/baseline blood tests exceeding any of the limits defined below:
- Serum alanine transaminase (ALT) or aspartate transaminase (AST) levels greater than 3 times the upper limit of normal values; total bilirubin \> 2.0mg/dl; Serum amylase or lipase levels greater than twice the upper limit of normal values; serum creatine phosphokinase (CK) level exceeding 3 xULN and confirmed on repeat testing in 2 weeks.
- Platelet count \< 75,000/mm(3)
- Serum creatinine level \> 2.0 mg/dl
Exclusion
Key Trial Info
Start Date :
September 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01867320
Start Date
September 5 2013
End Date
September 25 2018
Last Update
March 30 2023
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892