Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease
Our primary objective is to further characterize the mechanism by which alpha-1PI regulates CD4 counts.
HIV-1 infected patients will be initiated on PROLASTIN®-C (Alpha-1 Proteinase Inhibitor [Human], Grifols Biotherapeutics Inc.) or placebo. Uninfected volunteers will be untreated and will be monitored for comparison.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Safety and Efficacy of Prolastin®-C (α1Proteinase Inhibitor, α1PI) in Human Immunodeficiency Virus-Infected Subjects|
- CD4 counts [ Time Frame: 9 weeks after initiation of treatment ] [ Designated as safety issue: No ]It has been observed that CD4 counts and cholesterol levels are correlated and that there is cyclic variation in individuals with and without HIV.
- cholesterol levels [ Time Frame: 9 weeks after initiation of treatment ] [ Designated as safety issue: No ]CD4 T cells transport lipoproteins through blood and lymph and are correlated with cholesterol levels. Regulation of CD4 counts includes regulation of cholesterol levels.
|Study Start Date:||April 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: α1 Proteinase Inhibitor in HIV disease
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
Biological: α1 Proteinase Inhibitor
Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
Placebo Comparator: Placebo in HIV disease
Placebo (saline) weekly for 8 weeks
No Intervention: Uninfected controls
Blood collection only for 8 weeks
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731691
|United States, New York|
|New York, New York, United States, 10018|
|Principal Investigator:||Cynthia Bristow, PhD||Institute for Human Genetics and Biochemistry|