Therapy to Elevate CD4 Counts in HIV-1 Disease

Institute for Human Genetics and Biochemistry

Status and phase: Completed; Phase 3; Phase 2

Conditions: HIV Disease

Treatments: Biological: alpha-1-Proteinase Inhibitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01370018

R06-005

Details and patient eligibility

About

For more than 20 years, alpha-1-proteinase inhibitor therapy has been the standard treatment for patients who have inherited alpha-1-proteinase inhibitor deficiency. Adult patients with this condition eventually develop emphysema. Most HIV-1 patients who have low viral load also have alpha-1-proteinase inhibitor deficiency. The number of CD4 cells in blood increases when alpha-1-proteinase inhibitor increases. Patients will be asked to participate in a pilot study to see whether the use of Zemaira® (alpha-1-proteinase inhibitor) can increase blood levels of alpha-1-proteinase inhibitor and consequently increase CD4 counts.

Full description

HIV-1 patients will be asked to participate in a pilot study to see whether the use of Zemaira increases blood levels of alpha-1-proteinase inhibitor and consequently increase CD4 counts.

HIV-1 patients will receive weekly treatment with Zemaira for 8 weeks by intravenous infusion. Blood will be collected immediately prior to each infusion. Blood will be collected at each visit. Exploratory assessments and not pre-specified outcome measurements will include complete blood count, lymphocyte phenotype, HIV-1 viral load, lipid levels, blood chemistry, and markers of inflammation from patient medical records. Exploratory and not pre-specified outcome measures will include extended lymphocyte phenotype and lymphocyte function using residual blood collected.

Enrollment: 4 patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. HIV-1 patients must have confirmed HIV-1 disease, diagnosed using the standard criteria and be on antiretroviral therapy. Patients with inherited alpha-1 proteinase inhibitor deficiency (PIzz) must not have previously received alpha-1 proteinase inhibitor 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 (<500 HIV-1 RNA copies/ml) and CD4 counts more than 200 and less than 400 cells/uL.
3. Age at least 18 years and under 65 years.
4. HIV-1 patients must have active alpha-1 proteinase inhibitor below 11uM (normal is 18-53 uM).
5. HIV-1 patients must have one year history (prior to the study) with CD4 counts greater than 200 and less than 400 cells/uL.
6. Volunteers must have no evidence of malignancy.

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. Patients with more than 500 HIV RNA copies/mL.
5. Patients with more than 400 CD4 cells/uL.
6. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

alpha-1 proteinase inhibitor in HIV

Experimental group

Description:

HIV-1 infected individuals treated with Alpha-1 proteinase inhibitor

Treatment:

Biological: alpha-1-Proteinase Inhibitor