Dr. Michael Har-Noy says that the study regimen involves 28 treatment days. The protocol begins with intradermal AlloStimTM on the first and third days. Next, on day seven, one mL of AlloStimTM is infused. Two more intradermal AlloStimTM doses are on days 10 and 14, and then on day 17 a three mL dose is injected intravenously. Dr. Michael Har-Noy says the protocol concludes with intradermal doses on days 24 and 28 and a five mL intravenous AlloStimTM dose on day 28.

Dr. Michael Har-Noy says that the patient’s CD4/CD8 ratio and viral load will be measured at baseline and then on days 10, 21 and 29. The CD4/CD8 ratio and viral load will then be re-evaluated monthly for the next six months. Michael Har-Noy notes that study blood will be drawn on day zero and on days seven, 17, 27 before AlloStimTM is given. Blood mononuclear cells and plasma will be stored for future evaluation of HIV-specific immunity, Th1/Th2 balance, and cytokine bead array. A complete phenotype analysis will be performed on Day 60 and just before baseline.

Complete blood count, C-reactive protein, and complete metabolic profile measurements, to monitor protocol safety, will be performed at baseline and on days seven, 14, 21, and 28.

Dr. Michael Har-Noy says that the primary endpoints of the HIV-AlloStimTM protocol are:
• Changes in the patients’ steady state viremia at baseline and monthly six months following the 28 day protocol with the patient still on HAART medication.
• Patient tolerance of AlloStimTM and overall drug safety.
• Baseline variations, absolute counts and activation status of the patients’ CD4 and CD8 naïve and memory T cells.
• Variations in activation state and absolute counts of monocyte/macrophages.
• Alterations in amounts of interferon -gamma producing CD4 T in response to HIV antigens, as measured by ELISPOT or intracellular cytokine staining.

Dr. Michael Har-Noy says that the primary secondary endpoint is the time to viral burden increase the HAART drugs are stopped.

Dr. Michael Har-Noy adds that medical professionals and interested patients can gain more information about this study at www.immunocare.net.

For more detail visit at:- http://michaelharnoy.weebly.com/