Dr. Michael Har-Noy Describes His New Phase I/II trial of AlloStimTM in HIV Patients

Therapeutic HIV vaccines, says Dr. Michael Har-Noy, CEO of Immunovative Therapies, Ltd., are designed to control HIV infection by improving the body’s natural immunologic response. Currently there are no HIV vaccines that are approved by the FDA.
Dr. Michael Har-Noy goes on to say that Natural Killer (NK) cell and that Cytotoxic T lymphocyte (CTL) responses are crucial to the initial drop in HIV viral load seen in the first months after acute infection. These positive cellular immune responses decrease as the disease progresses and cannot be refreshed with antiretroviral therapy alone. Dr. Michael Har-Noy indicates that numerous published studies suggest a vaccine might help restore the cellular immune response and CTL and NK responses to the HIV virus.
Highly active antiretroviral therapy (HAART), says Dr. Michael Har-Noy, has been the most significant advance in HIV/AIDS medicine with respect to chronic suppression of the HIV virus. Many patients are well into their second decade of treatment, with plasma levels of HIV RNA undetectable by current clinical assays. However, adds Dr. Michael Har-Noy, HIV infection often persist in spite of effective antiretroviral therapies as evidenced by rapid return of viremia after antiretroviral therapy is stopped. This recurrence of viremia is likely due to the early establishment of a stable reservoir of latently infected cells. On-going antiviral therapy is necessary to contain this persistent infection in reservoirs, such as latently infected CD4+ lymphocytes and other cells of the macrophage-monocyte type.
Therefore, says Dr. Michael Har-Noy, life-long antiviral therapy is necessary to control the HIV virus. This therapy is very expensive and highly prone to drug resistance. Continual antiretroviral treatment also has many cumulative side effects, and the long-term effects of this kind of treatment remains unknown. Since current antiretroviral therapy regimens are effective and relatively safe, Dr. Michael Har-noy points out that the administration of any experimental anti-HIV drug in either a proof-of-concept feasibility study or in a trial incorporating HAART treatment interruption raises significant ethical questions as well as regulatory and study design issues. However, says Dr. Michael Har-Noy, such studies are absolutely vital if we wish to ultimately cure HIV infection. While the potential benefit to humanity of such studies is great, the benefit to early trial volunteers may be minimal.
Dr. Michael Har-Noy says that in his Phase I/II study, to minimize the risk for early participants, only patients with minimal or non-detectable viral loads will be entered. Not only are these patients less risky, but the infected-cell reservoirs in these participants may be smaller and thus more amenable to intervention. Patients will be kept on HAART therapy during the treatment phase with AlloStimTM. Dr. Michael Har-Noy adds that patients will only be eligible for HAART interruption if the exhibit a spike in viral load, indicating successful activation of the latent virus, followed by a drop in viral burden to baseline, indication control by the patient’s own immune system.
To minimize the risk of interrupting the HAART regimen, patients will be closely monitored and will resume HAART treatment immediately if virus replication is detected.
Patients interested in participating in this trial should go to www.immunocare.net for more information and for entry and exclusion criteria.