Dr. Michael LedermanScientists at Case Western Reserve University School of Medicine have received $2.5 million from the pharmaceutical company Gilead Sciences to test two never-before-combined HIV treatments on patients.
The research team will combine Interleukin-2 (IL-2), a naturally occurring protein that fights off diseased cells, with a lab-engineered antibody that targets HIV. Both HIV-suppressing drugs have been used separately for years — but never in combination.
“Administered alone, both IL-2 and certain monoclonal antibodies can reduce—but not necessarily eliminate—the presence of HIV in the body,” said lead researcher Dr. Michael Lederman, the Scott R. Inkley Professor of Medicine at Case Western Reserve in Cleveland, Ohio, and a member of amfAR’s Scientific Advisory Committee.
“Our study will go the next step and use them together. We want to see if they produce more of a wallop in tandem than when administered individually.”
IL-2 is approved by the Food and Drug Administration for treating certain cancers. The protein activates the latent HIV reservoir and natural killer (NK) cells that target the virus. HIV-neutralizing monoclonal antibodies bind to the surface of cells making HIV and tell the newly activated NK cells which cells to kill.
The study, which is set to start in the second half of 2017, will test the novel drug combination on 16 patients for 64 weeks. Participants in one treatment group will receive IL-2 and those in a second group will receive IL-2 plus a monoclonal antibody that targets HIV-making cells.
Researchers hope the size of the HIV reservoirs decreases in both groups and that the antibody makes the IL-2 treatment more powerful. Persistent reservoirs of virus not cleared by antiretroviral therapy represent the main barrier to a cure. A previous retrospective study found that IL-2 treatment can reduce their size.
“We think it’s important to try to confirm those findings in a prospective trial, and just as important, see if the addition of a monoclonal antibody enhances the activity of IL-2,” Lederman said.
Lederman and his colleagues are consulting with the National Institutes of Health’s Vaccine Research Center to determine which monoclonal antibody to use among several the Center has developed to prevent or treat infection.
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