A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy
( Difficulty with enrollment )
David M. Simpson
Information provided by (Responsible Party)
David M. Simpson, Icahn School of Medicine at Mount Sinai
First received: March 21, 2012
Last updated: September 14, 2016
Last Verified: September 2016
History of Changes
The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an effective treatment for HIV associated myelopathy.
Drug : Intravenous Immunoglobulin
Drug : Placebo
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|
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.
- 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 ]
|Study Start Date:||February 2012|
|Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Saline 2gr/kg over 2 days of saline
Placebo - 2gr/kg over 2 days of saline
Other Name: Saline
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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 LocationsChoosing 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
Locations Show More
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
Sponsors and CollaboratorsDavid M. Simpson
|Principal Investigator:||David Simpson, MD||Icahn School of Medicine at Mount Sinai|
|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|
|Study First Received:||March 21, 2012|
|Last Updated:||September 14, 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
Rho(D) Immune Globulin
ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.