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

NCT01561755 | Terminated Phase 4 Results

• 2 other identifiers: GCO 10-1108HS#: 11-02029
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV-associated Myelopathy

Keywords

HIV associated myelopathy

Outcome Measures

Primary Outcomes (1)

• Strength Scores

  Strength score as measured by pounds of force sustained in lower extremity strength.

  at 2 months

Secondary Outcomes (6)

• Walking Test

  at 2 months

• Urinary Function

  2 months

• Bowel Function

  2 months

• Hughes Function Score

  at 2 months

• Impression of Change Score - Participant

  at 2 months

Study Arms (2)

Intravenous Immunoglobulin

EXPERIMENTAL

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

Drug: Intravenous Immunoglobulin

Placebo

PLACEBO COMPARATOR

Saline 2gr/kg over 2 days of saline

Drug: Placebo

Interventions

Intravenous Immunoglobulin DRUG

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

Also known as: Privigen®, IVIG

Intravenous Immunoglobulin

Placebo DRUG

Placebo - 2gr/kg over 2 days of saline

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David M. Simpson: lead
• CSL Behring: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Immunoglobulins, Intravenous; Sodium Chloride

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Recruitment difficult with the widespread availability of IVIG which can be prescribed in an "off-label" fashion, the low incidence of new HIVM cases and a reluctance of this patient population to undergo randomization.

Results Point of Contact

• Title: Dr. David Simpson
• Organization: Icahn School of Medicine at Mount Sinai

david.simpson@mssm.edu

212-241-8748

Study Officials

• David Simpson, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 23, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 13, 2018
• Results First Posted: April 13, 2018

Record last verified: 2018-04

Locations

US (1)