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

NCT ID: NCT01561755

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-09-30

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.

Conditions

HIV-associated Myelopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intravenous Immunoglobulin

Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®

Group Type: EXPERIMENTAL

Intravenous Immunoglobulin

Intervention Type: DRUG

Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®

Placebo

Saline 2gr/kg over 2 days of saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo - 2gr/kg over 2 days of saline

Interventions

Intravenous Immunoglobulin

Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®

Intervention Type: DRUG

Placebo

Placebo - 2gr/kg over 2 days of saline

Intervention Type: DRUG

Other Intervention Names

Privigen®; IVIG; Saline

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: collaborator

David M. Simpson

OTHER

Sponsor Role: lead

Responsible Party

David M. Simpson

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Simpson, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

HS#: 11-02029

Identifier Type: -

Identifier Source: secondary_id

GCO 10-1108

Identifier Type: -

Identifier Source: org_study_id