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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01731691
Recruitment Status : Terminated (Potential non compliance with Protocol.)
First Posted : November 22, 2012
Last Update Posted : December 23, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
HIV Disease Biological: α1 Proteinase Inhibitor Phase 2 Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
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
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Other Names:
  • Prolastin
  • Prolastin-C
  • Zemaira
  • Glassia
Placebo Comparator: Placebo in HIV disease
Placebo (saline) weekly for 8 weeks
No Intervention: Uninfected controls
Blood collection only for 8 weeks


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. HIV-1 patients must have confirmed HIV-1 disease, diagnosed using the standard criteria and be on antiretroviral therapy. Uninfected volunteers will be age and gender matched.
  2. HIV-1 patients must have measurable disease, defined as HIV-1 infected patients on antiretroviral therapy with undetectable HIV RNA (<1000 HIV RNA copies/ml) and CD4 counts more than 200 and less than 600 cells/uL.
  3. Not have previously received α1PI augmentation therapy
  4. Age at least 18 years and under 65 years
  5. Capacity for and commitment to attend all protocol scheduled visits at ACRIA
  6. Life expectancy of greater than 5 years
  7. Patients must have lab values within the limits defined below:

    • WBC >4,1000/uL
    • ANC >1,000/uL
    • platelets >100,000//uL
    • total bilirubin 2-12 mg/dL
    • AST(SGOT)/ALT(SGPT) < or = 2.5 X upper limit of normal
    • creatinine Male : 0.50-1.30 mg/dL Female: 0.40-1.20 mg/dL
  8. HIV-1 patients must have active α1PI below 11 uM (normal is 18-53 uM)
  9. HIV-1 patients must have one year history (prior to the study) with CD4+ lymphocytes at levels greater than 200 and less than 400 cells/uL
  10. HIV-1 patients must have absence of symptoms suggestive of HIV-1 disease progression
  11. HIV-1 patients must have adequate suppression of virus (<400 HIV RNA/mL)
  12. HIV-1 patients must have a history of compliance with antiretroviral medication based on undetectable virus levels
  13. No evidence of malignancy
  14. The effects of Prolastin-C on the developing human fetus at the recommended therapeutic dose are unknown: At any time throughout the study, from the signing of the informed consent form until after the last study visit, all female and male subjects who are biologically capable of having children must agree and commit to use a reliable method of birth control.
  15. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. Recent illness that will prevent the patient from participating in required study activities
  2. Patients receiving other investigational agents
  3. Patients with known malignancies
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Prolastin-C
  5. IgA deficient patients
  6. Patients with ≥1000 HIV-1 RNA copies/ mL
  7. Patients with >600 CD4 cells/uL
  8. Uncontrolled illness including, but not limited to, ongoing or active infection, myeloid dysplastic syndrome, anemia, bone marrow failure, DiGeorge Syndrome, thymic disorders, or psychiatric illness/social situations that would limit compliance with study requirements
  9. Pregnant and breastfeeding women
  10. Refusal to give informed consent
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, New York
ACRIA
New York, New York, United States, 10018
Sponsors and Collaborators
Institute for Human Genetics and Biochemistry
AIDS Community Research Initiative of America
Grifols Biologicals Inc.
Investigators
Principal Investigator: Cynthia Bristow, PhD Institute for Human Genetics and Biochemistry
More Information

Publications:
Responsible Party: Institute for Human Genetics and Biochemistry
ClinicalTrials.gov Identifier: NCT01731691     History of Changes
Other Study ID Numbers: Prolastin-C in HIV disease
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protease Inhibitors
Alpha 1-Antitrypsin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors