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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 23, 2014
Last verified: October 2014

March 21, 2012
October 23, 2014
February 2012
June 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01561755 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in walking [ Time Frame: at baseline and at 2 months ] [ Designated as safety issue: No ]
    The study will assess the changes in walking from pre and post treatment.
  • Changes in urinary and bowel function [ Time Frame: at baseline and at 2 months ] [ Designated as safety issue: No ]
    The study will assess the changes in urinary and bowel function from pre and post treatment.
  • Changes in clinical disability [ Time Frame: at baseline and at 2 months ] [ Designated as safety issue: No ]
    The study will assess changes in clinical disability from pre and post treatment.
Not Provided
Not Provided
 
A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy
A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV-associated Myelopathy
  • Drug: Intravenous Immunoglobulin
    Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
    Other Names:
    • Privigen®
    • IVIG
  • Drug: Placebo
    Placebo - 2gr/kg over 2 days of saline
    Other Name: Saline
  • Experimental: Intravenous Immunoglobulin
    Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
    Intervention: Drug: Intravenous Immunoglobulin
  • Placebo Comparator: Placebo
    Saline 2gr/kg over 2 days of saline
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2016
June 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Mary-Catherine George, MM 212-241-0784 mary-catherine.george@mssm.edu
United States
 
NCT01561755
GCO 10-1108, HS#: 11-02029
No
David M. Simpson, Mount Sinai School of Medicine
David M. Simpson
CSL Behring
Principal Investigator: David Simpson, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP