NCT01561755

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: David M. Simpson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• HIV-associated Myelopathy

Interventions

Type	Name	Description
DRUG	Intravenous Immunoglobulin	Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
DRUG	Placebo	Placebo - 2gr/kg over 2 days of saline

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2012-03-23
• Last updated: 2018-04-13
• Results posted: 2018-04-13

Locations

1 site across 1 country: United States