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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
David M. Simpson, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01561755
First received: March 21, 2012
Last updated: March 29, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Change in strength scores pre and post treatment [ Time Frame: at baseline and at 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Changes in urinary and bowel function [ Time Frame: at baseline and at 2 months ] [ Designated as safety issue: No ]
  • Changes in clinical disability [ Time Frame: at baseline and at 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561755

Contacts
Contact: Mary-Catherine George, MM 212-241-0784 mary-catherine.george@mssm.edu

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

No publications provided

Responsible Party: David M. Simpson, Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01561755     History of Changes
Other Study ID Numbers: GCO 10-1108, HS#: 11-02029
Study First Received: March 21, 2012
Last Updated: March 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
HIV associated myelopathy

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

ClinicalTrials.gov processed this record on July 24, 2014