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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: HIV Disease

In brief

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.

Key facts

Study ID

NCT01731691

Run by

Institute for Human Genetics and Biochemistry

People needed

12

Starts

2012-04-01

Expected to finish

2014-07-01

Last updated by the study team

2020-08-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.
• Not have previously received α1PI augmentation therapy
• Age at least 18 years and under 65 years
• Capacity for and commitment to attend all protocol scheduled visits at ACRIA
• Life expectancy of greater than 5 years
• 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
• HIV-1 patients must have active α1PI below 11 uM (normal is 18-53 uM)
• 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
• HIV-1 patients must have absence of symptoms suggestive of HIV-1 disease progression
• HIV-1 patients must have adequate suppression of virus (<400 HIV RNA/mL)
• HIV-1 patients must have a history of compliance with antiretroviral medication based on undetectable virus levels
• No evidence of malignancy
• 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.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Recent illness that will prevent the patient from participating in required study activities
• Patients receiving other investigational agents
• Patients with known malignancies
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Prolastin-C
• IgA deficient patients
• Patients with ≥1000 HIV-1 RNA copies/ mL
• Patients with >600 CD4 cells/uL
• 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
• Pregnant and breastfeeding women
• Refusal to give informed consent

Where it is running

• ACRIA — New York, New York, United States

Full record on ClinicalTrials.gov

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