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HIV (Patient Information)

There are now over 34 million people living with HIV. The discovery of cocktails of Highly Active Anti-Retroviral Drugs (HAART) has change HIV infection from a terminal illness to a chronic disease. HAART, when used as directed, can result in viral suppression, improved quality of life and a near normalization of life span.  However, despite the potency of HAART to provide indefinite viral suppression, there are still limitations of this approach.  HAART drugs block various points in the life cycle of the virus. However, HAART can not eliminate the viral reservoirs.  This limitation requires that HAART cocktail regimens be taken for a lifetime. Not only is this requirement expensive and difficult to be fully compliant with, the long-term toxicities of these drugs and persistent HIV-associated inflammation are now becoming apparent. Despite virus control, complications including higher than normal risk for developing cardiovascular disease, cancer, osteoporosis and other end-organ diseases are becoming apparent. Thus, there is a need for novel therapeutic approaches that could eliminate the life-long adherence to expensive and potentially toxic antiretroviral drugs

There are two broadly defined categories of a cure for HIV infection:

functional cure can be defined as host-mediated control of HIV replication, in the absence of HAART.

sterilizing cure for HIV infection can be defined as the complete elimination of replication-competent virus.

Our goal is to develop an immunotherapy that will provide a sterilizing cure for the disease. In our research to-date, we are ready to begin testing what we believe will be a functional cure for HIV infection. 

In a pilot clinical study of AlloStim® immunotherapy with two HIV+ volunteers (the “Bangkok patient” and the “San Francisco” patient) that have been HIV+ for at least 20 years and on daily HAART therapy we have been able to achieve immune control of the virus. 

The “Bangkok” patient was viral suppressed below detectable limits with CD4 counts between 20-200. When placed on a brief HAART holiday, his viral load became detectable in 3 days. After he received AlloStim® immunotherapy and was placed on an HAART holiday, his viral load remained undetectable for 84 days. After 84 days, while his viral load was detectable his CD4 counts continued to rise and reached a set-point of 330-450.  He remained in this state of functional cure for 17 weeks before being placed back on HAART therapy. Once back on HAART therapy, his viral load returned to undetectable within 7 days.

The “San Francisco” patient also presented with undetectable viral load. His CD4 counts were in the 400-440 range. After AlloStim® immunotherapy and discontinuation of HAART therapy, his viral load remained undetectable for 55 days and his CD4 counts increased to over 700. He has now been on HAART holiday over 7 months. While his viral load is detectable, his CD4 counts have remained over 500. 

AlloStim® has the three features necessary for potential cure:

  1. Creation and/or enhancement of anti-HIV immunity
  2. Purge of the viral reservoir
  3. Protection of CD4 cells