A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-associated Myelopathy
Intervention: Intravenous Immunoglobulin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: David M. Simpson Official(s) and/or principal investigator(s): David Simpson, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
Overall contact: Mary-Catherine George, MM, Phone: 212-241-0784, Email: mary-catherine.george@mssm.edu
Summary
The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an
effective treatment for HIV associated myelopathy.
Clinical Details
Official title: A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in strength scores pre and post treatment
Secondary outcome: Changes in walkingChanges in urinary and bowel function Changes in clinical disability
Detailed description:
The purpose of this study is to determine whether or not intravenous immunoglobulin (lVlg),
brand name Privigen, is effective in treating a disorder called HIV-associated myelopathy
(HIVM). This drug is currently not approved by the Food and Drug Administration (FDA) for
treating this disorder.
HIVM is a spinal cord disease that occurs at any stage of HIV infection. It is not known
what causes this condition, but symptoms can include weakness in the lower body and problems
with frequent urination or problems with bowel function, trouble walking or performing
sexually.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Mary-Catherine George, MM, Phone: 212-241-0784, Email: mary-catherine.george@mssm.edu
Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States; Recruiting David Simpson, MD, Principal Investigator
Additional Information
Starting date: February 2012
Last updated: October 23, 2014
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