Dr. Michael Har-Noy says the initial protocol involves 28 days of treatment. Specifically, the regimen begins with intradermal AlloStimTM on days zero and three, followed by one mL of intravenous AlloStimTM on day seven. Two more intradermal AlloStimTM injections are given on days 10 and 14, followed by three mL of AlloStimTM on day 17. Dr. Michael Har-Noy finishes the protocol with two more intradermal AlloStimTM injections on days 24 and 28, followed by a final five ml intravenous dose of AlloStimTM on day 28.

Dr. Michael Har-Noy details that the patient’s viral load and CD4/CD8 ratio will be measured at baseline on day zero and again on days 10, 21 and 29. These parameters will then be assessed every 28-32 days thereafter for six months. Dr. Michael Har-Noy says that blood for research measurements will be drawn at or before baseline (day zero) and on days seven, 17, 27 before the intravenous infusions of AlloStimTM. Peripheral blood mononuclear cells and plasma will be stored frozen for future analysis of Th1/Th2 balance, HIV-specific immunity, and cytokine bead array. A detailed phenotype analysis will be conducted prior to baseline and on day 60.

Complete blood count, complete metabolic profile, and C-reactive protein laboratory tests (to monitor safety of therapy) will be drawn and analysed at baseline and on days seven, 14, 21, and 28.

Dr. Michael Har-Noy outlines the primary outcome measures of the HIV-AlloStimTM study as follows:

Changes in the patients’ steady state viremia or viral set point at baseline and monthly thereafter for six months after the completion of the 28 day protocol while remaining on the HAART regimen.

Safety and tolerability of the AlloStimTM treatments.

Changes from baseline and absolute counts and activation status of the study patients’ CD4 and CD8 naïve and memory T cells

Changes in study patients’ absolute counts and activation state of monocyte/macrophages.

Changes in the number of interferon -gamma generating CD4 T cells per million peripheral blood mononuclear cells, in response to HIV antigens, as measured by intracellular cytokine staining or ELISPOT.

Dr. Michael Har-Noy indicates that the main secondary outcome measure will be the time to the patients’ viral burden increase after interruption of their HAART regimen.

Dr. Michael Har-Noy encourages patients and healthcare professionals to visit www.immunocare.net for more information about this study.