HIV-associated Myelopathy Clinical Trial
Official title:
A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy
| Verified date | April 2018 |
| Source | Icahn School of Medicine at Mount Sinai |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an effective treatment for HIV associated myelopathy.
| Status | Terminated |
| Enrollment | 12 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Documented history of HIV infection. - Age = 18 - Males and females are eligible. Subjects must agree to practice birth control or abstinence. Females of child-bearing potential must have a negative urine pregnancy within 14 days prior to study entry. - Adequate baseline organ function including the following laboratory values within 14 days prior to study entry: - Adequate liver function with ALT, AST and alkaline phosphatase = 5 times upper limit of normal (ULN). - Total bilirubin = 2.5 mg/dL Creatinine < 2.3 Serum vitamin B12 level = 200 pg/ml - Diagnosis of HIVM by a neurologist - defined as: - - Presence of at least two of the following symptoms: - - Paresthesias and/or numbness in the lower extremities or in all four limbs; Weakness of the limbs, with predominance in the lower extremities; Unsteady, stiff or uncoordinated gait; Sensation of electrical shock through the back or the legs upon flexion of the neck (L'Hermitte's sign); Stiffness or spasm in the lower extremities; Urinary frequency, urgency, incontinence or retention; Fecal incontinence or retention; Sexual dysfunction with erectile impairment in men; - - Presence of at least two of the following neurologic signs: - - Reduction in vibratory or position sensation in the lower extremities; Hyperactive deep tendon reflexes; Abnormal response to plantar stimulation (Babinski sign); Presence of L'Hermitte sign (electrical-type sensation down the back, provoked by flexion of the neck); Weakness in the lower extremities or in all four limbs; Spastic or ataxic gait - Antiretroviral regimen stable 2 months prior to the entry of the study. Exclusion Criteria: - Presence of acute, active, opportunistic infection, except oral thrush, orogenital or rectal herpes and MAI bacteremia within 2 weeks before randomization. - Evidence of another contributing cause for myelopathy. - Women who are pregnant, breast-feeding or planning a pregnancy. - Active abuse of drugs or alcohol, which in the opinion of the investigator would interfere with the subject's ability to comply with the protocol. - Any neurologic or systemic conditions, which in the opinion of the investigator would interfere with the evaluation of the subject. - Presence of significant cardiac, pulmonary or renal disease that would place the subject at risk for the fluid and protein load of IVIg. - History of hypersensitivity to immunoglobulin, or IgA deficiency; Vaccination with live viruses within the past 90 days; Patients receiving IVIg or other immunomodulatory agent (cyclosphosphamide, azathioprine, corticosteroids, tacrolimus, cyclosporine, OKT3, plasma exchange, alpha, beta or gamma interferon) within the past 3 months. - Patients in whom muscle dynamometry can not be performed for any reason. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| David M. Simpson | CSL Behring |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Strength Scores | Strength score as measured by pounds of force sustained in lower extremity strength. | at 2 months | |
| Secondary | Walking Test | 2 minute walking test | at 2 months | |
| Secondary | Urinary Function | 0 = Normal bladder function, 1 = Asymptomatic on current treatment, 2 = Urinary frequency, hesitancy, urgency, with no incontinence, 3 = Occasional urinary incontinence (once or more during the last month but not every week) or intermittent catheterization, 4 = Frequent urinary incontinence, or occasional incontinence despite regular catheterization, 5 = Daily urinary incontinence or permanent catheter | 2 months | |
| Secondary | Bowel Function | 0 = No bowel problems, 1 = Asymptomatic on current drug tx or constipation not requiring any tx, 2 = Constipation requiring laxative or suppositories or fecal urgency, 3 = Constipation requiring the use of an enema, 4 = Constipation requiring manual evacuation of stools or occasional fecal incontinence (once or more during the last month but not every week, 5 = Weekly fecal incontinence | 2 months | |
| Secondary | Hughes Function Score | 0 = Normal strength; 1 = minor symptoms but capable of running; 2 = The subject is able to walk 30 ft. but unable to run; 3 = The subject is able to walk 30 ft. with the assistance of one person; 4 = A walker or cane; 5 = The subject is unable to walk. | at 2 months | |
| Secondary | Impression of Change Score - Participant | The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment 1. Marked improvement; 2 Moderate Improvement; 3 Minimal Improvement; 4 No Change; 5 Minimal Worsening; 6 Moderate Worsening; 7 Marked worsening | at 2 months | |
| Secondary | Impression of Change Score - Clinician | The clinician measure of Global Impression of Change reflects the clinician's view about the efficacy of treatment as measured by 1. Marked improvement; 2 Moderate Improvement; 3 Minimal Improvement; 4 No Change; 5 Minimal Worsening; 6 Moderate Worsening; 7 Marked worsening | at 2 months |