Therapy to Elevate CD4 Counts in HIV-1 Disease

• Lymphocyte Phenotype [ Time Frame: 9 or 13 weeks. ] [ Designated as safety issue: Yes ]
  CD3, CD4, and CD8 cells/ul were assessed at the same time of day on the same day of the week each week for the duration of the study
  
  

• HIV-1 viral load [ Time Frame: 9 or 13 weeks. ] [ Designated as safety issue: Yes ]
  HIV -1 RNA copies/ml were assessed at the same time of day on the same day of the week each week for the duration of the study
  
  
• Lipid levels [ Time Frame: 9 or 13 weeks. ] [ Designated as safety issue: Yes ]
  Total cholesterol, HDL, LDL, and triglycerides (mg/dL) were assessed at the same time of day on the same day of the week each week for the duration of the study
  
  
• Blood Chemistry [ Time Frame: Multiple blood chemistry measures as listed in the Description were assessed once during the study between the 6th and 8th week. ] [ Designated as safety issue: Yes ]
  Total protein (gm/dL), Albumin (gm/dL), and Globulin (gm/dL), Glucose (mg/dL), Sodium (mmol/dL), Potassium (mmol/dL), Chloride (mmol/dL), CO2 (mmol/dL), BUN (mg/dL), Creatinine (mg/dL), Calcium (mg/dL), Uric acid (mg/dL), Iron (mcg/dL), Total bilirubin (mg/dL), LDH (u/L), Alk Phos (u/L), AST (u/L), Phosphorous (mg/dL), ALT (u/L), and G-GTP (u/L)
  
  
• Immune Activation [ Time Frame: Cytokine release and signaling by CD4 lymphocytes were assessed once every 3 weeks for the duration of the study which lasted either 9 or 13 weeks. ] [ Designated as safety issue: No ]
  To assess whether the new crop of CD4 lymphocytes were immunocompetent, CD4 cells were harvested from blood and activated. This outcome measure was conducted only when the research subject had sufficient CD4 lymphocytes to perform the test. CD4 lymphocytes were stimulated using antibodies reactive with CD2, CD3, and CD28 for 3 days. Culture supernatant was measured for release of cytokines IL-2, IL-4, IL-10, and IFN gamma (pg/ml). Cells were harvested and examined for NFkB activation using flow cytometry which measured log fluorescence of stimulated cells as compared to unstimulated cells.
  
  
• Extended Lymphocyte Phenotype [ Time Frame: the duration of the study lasting either 9 or 13 weeks. ] [ Designated as safety issue: No ]
  CD184, CD195, CD45RA, CD45RO, CD34 and CD25 (cells/ul) were assessed at the same time of day on the same day of the week each week.
  
  
• Complete blood count and differential [ Time Frame: the duration of the study lasting either 9 or 13 weeks. ] [ Designated as safety issue: No ]
  Granulocytes, lymphocytes, monocytes, NK cells, basophils, and eosinophils (cells/ul) plus platelets (thousands/ul) were assessed at the same time of day on the same day of the week each week.
  
  

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.