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

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 (<400 HIV RNA copies/ml) and CD4 counts more than 200 and less than 400 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 ≥400 HIV-1 RNA copies/ mL
7. Patients with >400 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