drugset / Trial / NCT01731691
Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease
Phase 2/3
Terminated
12 enrolled
Institute for Human Genetics and Biochemistry
AIDS Community Research Initiative of America · collabGrifols Biologicals, LLC · collab
RandomizedParallel-groupTriple-blindBasic science
Summary
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.
Timeline
- Start
- 2012-04
- Primary completion
- 2014-07
- Completion
- 2014-07
Publications
- Background Bristow CL, Babayeva MA, LaBrunda M, Mullen MP, Winston R. alpha1Proteinase inhibitor regulates CD4+ lymphocyte levels and is rate limiting in HIV-1 disease. PLoS One. 2012;7(2):e31383. doi: 10.1371/journal.pone.0031383. Epub 2012 Feb 17.
- Background Bristow CL, Patel H, Arnold RR. Self antigen prognostic for human immunodeficiency virus disease progression. Clin Diagn Lab Immunol. 2001 Sep;8(5):937-42. doi: 10.1128/CDLI.8.5.937-942.2001.
- Results Bristow CL, Ferrando-Martinez S, Ruiz-Mateos E, Leal M, Winston R. Development of Immature CD4+CD8+T Cells Into Mature CD4+ T Cells Requires Alpha-1 Antitrypsin as Observed by Treatment in HIV-1 Infected and Uninfected Controls. Front Cell Dev Biol. 2019 Nov 21;7:278. doi: 10.3389/fcell.2019.00278. eCollection 2019.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 120 mg/kg | Intravenous |