Therapy to Elevate CD4 Counts in HIV-1 Disease

Completed · Phase 2/Phase 3

Conditions studied: HIV Disease

In brief

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.

Key facts

Study ID

NCT01370018

Run by

Institute for Human Genetics and Biochemistry

People needed

4

Starts

2006-12-01

Expected to finish

2007-02-01

Last updated by the study team

2021-09-28

Who can join

Age: 30 and older, up to 70. Sex: male. 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. 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.
• 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.
• Age at least 18 years and under 65 years.
• HIV-1 patients must have active alpha-1 proteinase inhibitor below 11uM (normal is 18-53 uM).
• HIV-1 patients must have one year history (prior to the study) with CD4 counts greater than 200 and less than 400 cells/uL.
• Volunteers must have no evidence of malignancy.

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.
• Patients with more than 500 HIV RNA copies/mL.
• Patients with more than 400 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.

Where it is running

• Cabrini Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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