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

This study has been terminated.
(Difficulty with enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561755
First Posted: March 23, 2012
Last Update Posted: September 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CSL Behring
Information provided by (Responsible Party):
David M. Simpson, Icahn School of Medicine at Mount Sinai
  Purpose
The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an effective treatment for HIV associated myelopathy.

Condition Intervention Phase
HIV-associated Myelopathy Drug: Intravenous Immunoglobulin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy

Resource links provided by NLM:


Further study details as provided by David M. Simpson, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Change in strength scores pre and post treatment [ Time Frame: at baseline and at 2 months ]
    Study will assess improvement in lower extremity strength from pre and post treatment.


Secondary Outcome Measures:
  • Changes in walking [ Time Frame: at baseline and at 2 months ]
  • Changes in urinary and bowel function [ Time Frame: at baseline and at 2 months ]
  • Changes in clinical disability [ Time Frame: at baseline and at 2 months ]

Enrollment: 17
Study Start Date: February 2012
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous Immunoglobulin
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Drug: Intravenous Immunoglobulin
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Other Names:
  • Privigen®
  • IVIG
Placebo Comparator: Placebo
Saline 2gr/kg over 2 days of saline
Drug: Placebo
Placebo - 2gr/kg over 2 days of saline
Other Name: Saline

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561755


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
David M. Simpson
CSL Behring
Investigators
Principal Investigator: David Simpson, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: David M. Simpson, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01561755     History of Changes
Other Study ID Numbers: GCO 10-1108
HS#: 11-02029
First Submitted: March 21, 2012
First Posted: March 23, 2012
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by David M. Simpson, Icahn School of Medicine at Mount Sinai:
HIV associated myelopathy

Additional relevant MeSH terms:
Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs


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