Therapy to Elevate CD4 Counts in HIV-1 Disease

HIV Disease Clinical Trial

Official title: Zemaira (Alpha-1-Proteinase Inhibitor) Therapy in HIV-1 Disease

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Disease
• HIV Infections

• NCT number: NCT01370018
• Study type: Interventional
• Source: Institute for Human Genetics and Biochemistry
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2006
• Completion date: February 2007