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Proteinase Inhibitor

Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease

Phase 2 & 3
Waitlist Available
Led By Cynthia Bristow, PhD
Research Sponsored by Institute for Human Genetics and Biochemistry
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks after initiation of treatment
Awards & highlights
All Individual Drugs Already Approved

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.

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks after initiation of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks after initiation of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CD4 Counts
CD4/CD8 Ratio
CD8

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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

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Who is running the clinical trial?

Institute for Human Genetics and BiochemistryLead Sponsor
1 Previous Clinical Trials
4 Total Patients Enrolled
AIDS Community Research Initiative of AmericaOTHER
Grifols Biologicals, LLCIndustry Sponsor
32 Previous Clinical Trials
9,444 Total Patients Enrolled
Cynthia Bristow, PhDPrincipal InvestigatorInstitute for Human Genetics and Biochemistry
~1 spots leftby Dec 2025
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