CTNPT 031: The HAVARTI Trial

About the Study

This short-term pilot trial will test the safety, tolerance, and efficacy of vedolizumab, a monoclonal antibody, as a functional cure for chronic HIV infection. A functional cure refers to an intervention that would allow people living with HIV to stop taking antiretroviral therapy (ART) without experiencing viral rebound, progressive infection, and health consequences. Vedolizumab, also called anti-47 integrin mAb, is a safe, licensed treatment for inflammatory bowel disease.

Background

In most cases, interruption of regular ART adherence results in viral rebound and the spread of HIV throughout the body. A recently published study showed that, after treatment with vedolizumab, viral load suppression and preserved CD4 count were maintained in monkeys with SIV (the primate equivalent of HIV) who were previously on stable ART. In the context of HIV, vedolizumabs mechanism of action is not well understood. The drug may work by preventing a specific type of immune cell (one that is often targeted by HIV) from entering into the tissue of the gut, an area of significant inflammation and viral activity during infection.

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