Clinical trial NCT01561755: A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy
Official title: A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV-associated Myelopathy
Keywords: HIV associated myelopathy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2012-03-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Strength Scores
timeFrame: at 2 months
Secondary outcomes:
measure: Walking Test
timeFrame: at 2 months
measure: Urinary Function
timeFrame: 2 months
measure: Bowel Function
timeFrame: 2 months
measure: Hughes Function Score
timeFrame: at 2 months
measure: Impression of Change Score - Participant
timeFrame: at 2 months
measure: Impression of Change Score - Clinician
timeFrame: at 2 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Simpson, MD
role: PRINCIPAL_INVESTIGATOR
References: