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

NCT01731691 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-08-31

Study results available
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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.

Conditions

  • HIV Disease

Interventions

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.

DRUG

Placebos

Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.

Sponsors & Collaborators

  • AIDS Community Research Initiative of America

    collaborator OTHER

  • Grifols Biologicals, LLC

    collaborator INDUSTRY

  • Institute for Human Genetics and Biochemistry

    lead OTHER

Principal Investigators

  • Cynthia Bristow, PhD · Institute for Human Genetics and Biochemistry

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-07-31
Completion
2014-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01731691 on ClinicalTrials.gov