Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease
Palo Alto (17 mi)Overseen byCynthia Bristow, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Institute for Human Genetics and Biochemistry
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Treatment Details
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: α1 Proteinase Inhibitor in HIV diseaseExperimental Treatment1 Intervention
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
Group II: Uninfected controlsActive Control1 Intervention
Blood collection only for 8 weeks
Group III: Placebo in HIV diseasePlacebo Group1 Intervention
Placebos weekly for 8 weeks
Find a clinic near you
Research locations nearbySelect from list below to view details:
ACRIANew York, NY
Loading ...
Who is running the clinical trial?
Institute for Human Genetics and BiochemistryLead Sponsor
AIDS Community Research Initiative of AmericaCollaborator
Grifols Biologicals, LLCIndustry Sponsor