A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy

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

The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an effective treatment for HIV associated myelopathy.

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 walking

Changes 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.

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.

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

Starting date: February 2012
Last updated: October 23, 2014