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

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ClinicalTrials.gov Identifier: NCT01561755
Recruitment Status : Terminated (Difficulty with enrollment)
First Posted : March 23, 2012
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
David M. Simpson, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV-associated Myelopathy
Interventions Drug: Intravenous Immunoglobulin
Drug: Placebo
Enrollment 12
Recruitment Details Participants were recruited from three main sources: the clinical NeuroAIDS practices of the investigators; pre-existing observational research studies (Manhattan HIV Brain Bank and the CNS HIV Antiretroviral Effects Research (CHARTER)); and via a referral network of regional HIV care providers. for a total of four years 2012-2016.
Pre-assignment Details  
Arm/Group Title Intravenous Immunoglobulin Placebo
Hide Arm/Group Description Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen® Saline 2gr/kg over 2 days of saline
Period Title: Overall Study
Started 6 6
Completed 6 5
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Intravenous Immunoglobulin Placebo Total
Hide Arm/Group Description Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen® Saline 2gr/kg over 2 days of saline Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
48
(29 to 69)
58
(29 to 68)
48
(29 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
1
  16.7%
1
  16.7%
2
  16.7%
Male
5
  83.3%
5
  83.3%
10
  83.3%
Number of participant with undetectable Viral Load   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
1
  16.7%
0
   0.0%
1
   8.3%
[1]
Measure Description: Number of participants with undetectable viral load <20 copies/ml
mean CD4+  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 6 participants 6 participants 12 participants
620  (223) 564  (270) 592  (212)
1.Primary Outcome
Title Strength Scores
Hide Description Strength score as measured by pounds of force sustained in lower extremity strength.
Time Frame at 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Immunoglobulin Placebo
Hide Arm/Group Description:
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Saline 2gr/kg over 2 days of saline
Overall Number of Participants Analyzed 6 5
Mean (Standard Deviation)
Unit of Measure: pounds of force
Hip Flexion 14.0  (32.7) 1.9  (13.4)
Knee Flexion 12.4  (14.4) 10.3  (14.5)
Ankle Dorsiflexion 1.7  (8.2) -6.0  (5.2)
Lower extremity - sum of all three 28.2  (49.2) 6.2  (28.9)
2.Secondary Outcome
Title Walking Test
Hide Description 2 minute walking test
Time Frame at 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant in placebo group in wheelchair and unable to complete the walking test
Arm/Group Title Intravenous Immunoglobulin Placebo
Hide Arm/Group Description:
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Saline 2gr/kg over 2 days of saline
Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: meters
93.49  (42.57) 112.08  (102.00)
3.Secondary Outcome
Title Urinary Function
Hide Description 0 = Normal bladder function, 1 = Asymptomatic on current treatment, 2 = Urinary frequency, hesitancy, urgency, with no incontinence, 3 = Occasional urinary incontinence (once or more during the last month but not every week) or intermittent catheterization, 4 = Frequent urinary incontinence, or occasional incontinence despite regular catheterization, 5 = Daily urinary incontinence or permanent catheter
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Immunoglobulin Placebo
Hide Arm/Group Description:
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Saline 2gr/kg over 2 days of saline
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: units on a scale
2.6
(0 to 5)
2.5
(0 to 5)
4.Secondary Outcome
Title Bowel Function
Hide Description 0 = No bowel problems, 1 = Asymptomatic on current drug tx or constipation not requiring any tx, 2 = Constipation requiring laxative or suppositories or fecal urgency, 3 = Constipation requiring the use of an enema, 4 = Constipation requiring manual evacuation of stools or occasional fecal incontinence (once or more during the last month but not every week, 5 = Weekly fecal incontinence
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Immunoglobulin Placebo
Hide Arm/Group Description:
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Saline 2gr/kg over 2 days of saline
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: units on a scale
1.3
(0 to 5)
2.07
(0 to 5)
5.Secondary Outcome
Title Hughes Function Score
Hide Description 0 = Normal strength; 1 = minor symptoms but capable of running; 2 = The subject is able to walk 30 ft. but unable to run; 3 = The subject is able to walk 30 ft. with the assistance of one person; 4 = A walker or cane; 5 = The subject is unable to walk.
Time Frame at 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Immunoglobulin Placebo
Hide Arm/Group Description:
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Saline 2gr/kg over 2 days of saline
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: units on a scale
3
(2 to 4)
3.2
(1 to 5)
6.Secondary Outcome
Title Impression of Change Score - Participant
Hide Description The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment 1. Marked improvement; 2 Moderate Improvement; 3 Minimal Improvement; 4 No Change; 5 Minimal Worsening; 6 Moderate Worsening; 7 Marked worsening
Time Frame at 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Immunoglobulin Placebo
Hide Arm/Group Description:
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Saline 2gr/kg over 2 days of saline
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: units on a scale
3.58
(2 to 5)
3.7
(2 to 4)
7.Secondary Outcome
Title Impression of Change Score - Clinician
Hide Description The clinician measure of Global Impression of Change reflects the clinician's view about the efficacy of treatment as measured by 1. Marked improvement; 2 Moderate Improvement; 3 Minimal Improvement; 4 No Change; 5 Minimal Worsening; 6 Moderate Worsening; 7 Marked worsening
Time Frame at 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Immunoglobulin Placebo
Hide Arm/Group Description:
Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Saline 2gr/kg over 2 days of saline
Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: units on a scale
3.58
(2 to 5)
4
(3 to 5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Immunoglobulin Placebo
Hide Arm/Group Description Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen® Saline 2gr/kg over 2 days of saline
All-Cause Mortality
Intravenous Immunoglobulin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Immunoglobulin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous Immunoglobulin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/6 (0.00%)    
General disorders     
Mild headache  1/6 (16.67%)  1 0/6 (0.00%)  0
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David Simpson
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-8748
Responsible Party: David M. Simpson, 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
Results First Submitted: March 6, 2018
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018