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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intravenous Immunoglobulin Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Placebo Saline 2gr/kg over 2 days of saline

Participant Flow:   Overall Study
    Intravenous Immunoglobulin   Placebo
STARTED   6   6 
COMPLETED   6   5 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intravenous Immunoglobulin Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
Placebo Saline 2gr/kg over 2 days of saline
Total Total of all reporting groups

Baseline Measures
   Intravenous Immunoglobulin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Years]
Mean (Full Range)
 48 
 (29 to 69) 
 58 
 (29 to 68) 
 48 
 (29 to 68) 
Sex: Female, Male 
[Units: Participants]
Count of 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] 
[Units: Participants]
Count of Participants
 1   0   1 
[1] Number of participants with undetectable viral load <20 copies/ml
mean CD4+ 
[Units: Cells/mm^3]
Mean (Standard Deviation)
 620  (223)   564  (270)   592  (212) 


  Outcome Measures

1.  Primary:   Strength Scores   [ Time Frame: at 2 months ]

2.  Secondary:   Walking Test   [ Time Frame: at 2 months ]

3.  Secondary:   Urinary Function   [ Time Frame: 2 months ]

4.  Secondary:   Bowel Function   [ Time Frame: 2 months ]

5.  Secondary:   Hughes Function Score   [ Time Frame: at 2 months ]

6.  Secondary:   Impression of Change Score - Participant   [ Time Frame: at 2 months ]

7.  Secondary:   Impression of Change Score - Clinician   [ Time Frame: at 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: david.simpson@mssm.edu



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