Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease
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|ClinicalTrials.gov Identifier: NCT01731691|
Recruitment Status : Terminated (Potential non compliance with Protocol.)
First Posted : November 22, 2012
Last Update Posted : December 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Disease||Biological: α1 Proteinase Inhibitor||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Safety and Efficacy of Prolastin®-C (α1Proteinase Inhibitor, α1PI) in Human Immunodeficiency Virus-Infected Subjects|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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
- CD4 counts [ Time Frame: 9 weeks after initiation of treatment ]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 ]CD4 T cells transport lipoproteins through blood and lymph and are correlated with cholesterol levels. Regulation of CD4 counts includes regulation of cholesterol levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731691
|United States, New York|
|New York, New York, United States, 10018|
|Principal Investigator:||Cynthia Bristow, PhD||Institute for Human Genetics and Biochemistry|