Therapy to Elevate CD4 Counts in HIV-1 Disease
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 30 - 70 |
| Updated: | 10/14/2017 |
| Start Date: | December 2006 |
| End Date: | February 2007 |
Zemaira (Alpha-1-Proteinase Inhibitor) Therapy in HIV-1 Disease
For more than 20 years, alpha-1-Proteinase Inhibitor therapy (Zemaira®) has been the standard
treatment for patients who have too little alpha-1-Proteinase Inhibitor in blood. Adult
patients with this condition eventually develop emphysema. Most HIV-1 patients who have low
viral load also have too little alpha-1-Proteinase Inhibitor in blood. Recent strong evidence
shows that the number of CD4 cells in blood goes up when alpha-1-Proteinase Inhibitor goes
up. Patients were asked to participate in a pilot study to see whether the use of Zemaira®
(alpha-1-Proteinase Inhibitor) would increase blood levels of alpha-1-Proteinase Inhibitor
and consequently increase CD4 cells.
treatment for patients who have too little alpha-1-Proteinase Inhibitor in blood. Adult
patients with this condition eventually develop emphysema. Most HIV-1 patients who have low
viral load also have too little alpha-1-Proteinase Inhibitor in blood. Recent strong evidence
shows that the number of CD4 cells in blood goes up when alpha-1-Proteinase Inhibitor goes
up. Patients were asked to participate in a pilot study to see whether the use of Zemaira®
(alpha-1-Proteinase Inhibitor) would increase blood levels of alpha-1-Proteinase Inhibitor
and consequently increase CD4 cells.
HIV-1 patients were asked to participate in a pilot study to see whether the use of Zemaira®
would increase blood levels of alpha-1-Proteinase Inhibitor and consequently increase CD4
cells. HIV-1 patients were specifically selected to receive Zemaira® therapy if they had <500
HIV-1 RNA copies/ml, <200 CD4 cells/ul, below normal alpha-1-Proteinase Inhibitor, and were
on antiretroviral therapy and in general good health.
Patients received an I.V. infusion of Zemaira® once a week for 8 or 12 weeks and returned one
week following the final infusion for blood collection. Each session lasted approximately 45
minutes. Each infusion was less than 30 minutes. At the time of infusion, patients were
admitted to the hospital and 3 tablespoons of blood was collected. Blood was used to monitor
viral load, CD4 cell numbers and function, cholesterol, triglycerides, LDL and HDL, and
alpha-1-Proteinase Inhibitor levels.
would increase blood levels of alpha-1-Proteinase Inhibitor and consequently increase CD4
cells. HIV-1 patients were specifically selected to receive Zemaira® therapy if they had <500
HIV-1 RNA copies/ml, <200 CD4 cells/ul, below normal alpha-1-Proteinase Inhibitor, and were
on antiretroviral therapy and in general good health.
Patients received an I.V. infusion of Zemaira® once a week for 8 or 12 weeks and returned one
week following the final infusion for blood collection. Each session lasted approximately 45
minutes. Each infusion was less than 30 minutes. At the time of infusion, patients were
admitted to the hospital and 3 tablespoons of blood was collected. Blood was used to monitor
viral load, CD4 cell numbers and function, cholesterol, triglycerides, LDL and HDL, and
alpha-1-Proteinase Inhibitor levels.
Inclusion Criteria:
- Patients were selected if they had <500 HIV-1 RNA copies/ml, < 200 CD4 cells/ul, <
11uM alpha-1-Proteinase Inhibitor, were receiving antiretroviral therapy, and were in
general good health.
- Because of the small number of patients to be evaluated (n=4), only men were be
included in the pilot study.
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