Temple’s HIV treatment undergoes clinical trial

The intravenous therapy could make a significant impact on cases of HIV and its stigma.

Tricia Burdo (left), a microbiology, immunology and inflammation professor, and Kamel Khalili, chair of the department of microbiology, immunology and inflammation and a cofounder of Excision BioTherapeutics, conduct research at the Lewis Katz School of Medicine at Temple University. | RYAN BRANDENBERG / COURTESY

Kevin Hackett was diagnosed with HIV in 1983, when people with the disease were heavily stigmatized by the federal government and those who did not have the virus. 

“You were diagnosed that week and you die the next following week,” said Hackett, 59, who lives on Roosevelt Boulevard. 

Hackett, now living with AIDS, takes one antiretroviral pill and up to 15 pills for related ailments per day. A new treatment that would allow people to stop relying on a variety of antiretroviral medications would make a world of difference, Hackett said. 

Temple University researchers developed an intravenous therapy, called EBT-101, that seeks to remove HIV DNA from infected cells using gene editing technology called CRISPR. It is currently being tested for safety and effectiveness in clinical trials. 

The treatment is potentially a “functional cure” for HIV, meaning patients could live without their antiretroviral therapy, a current treatment for the virus, said Dr. William Kennedy, senior vice president of Excision BioTherapeutics who is leading the clinical trial. 

Typically, a person with HIV will take their antiretroviral therapy indefinitely, Kennedy wrote in an email to The Temple News. EBT-101 can be administered as a single dose but cannot be readministered due to an acquired immune response from the first dose. 

“I’ve been going through some different stages now from having the virus for so long,” Hackett said. “So it will be wonderful. It would be magnificent.”

The study, led by Excision BioTherapeutics, began in January and is currently expected to end in March 2025. The clinical trial includes nine volunteers who are men between the ages of 18 and 60 years old and have been taking antiretroviral therapy for HIV for more than two years.

While antiretroviral therapy suppresses symptoms of HIV/AIDS, it does not extract HIV from infected cells, like EBT-101 aims to do, said Tricia Burdo, a microbiology, immunology and inflammation professor who helped lead and develop Temple’s research.

“Until there’s some way to remove that DNA then really we’re never going to be cured of the disease,” said Burdo, who also serves on the Scientific Advisory Board for Excision BioTherapeutics. 

The success of EBT-101 in clinical trials would significantly reduce case counts among vulnerable populations, like Black and Brown individuals, and the physical effects of HIV in individuals, like inflammation, said Keisha Gabbidon-Howell, supervisor of prevention and education at Bebashi, a local sexual health education and prevention organization located at Spring Garden Street near 13th. 

New cases of HIV in Philadelphia declined consistently between 2012 and 2020, according to the Philadelphia Department of Public Health’s 2020 report on HIV in Philadelphia.

There were 18,621 people living with diagnosed HIV in Philadelphia in 2020, 332 of whom were diagnosed in 2020, according to the report. 

After this clinical trial is completed, Excision BioTherapeutics will conduct one or two more studies with a larger group of people to further evaluate safety and efficacy. For the following 15 years, participants will participate in periodic blood tests and questionnaires. 

EBT-101 could also help decrease the stigma surrounding HIV, transmission or current treatments, Gabbidon-Howell said. 

“Over the years, education has helped try to turn the tide a little bit,” Gabbidon-Howell said. “However, it is still associated with, not to such a great degree, but to some degree, being promiscuous or being dirty.”

Garvin Lewis was diagnosed with HIV in 2009. Every time he meets someone new and mentions his diagnosis, he braces for a possible negative reaction. 

“For the most part, I’ve had positive reactions,” said Lewis, 42, who lives on 67th Street and Haverford. “But it’s always the one or two though, kind of taken like, ‘oh, maybe we shouldn’t drink from the same cup, we shouldn’t kiss.’” 

Anyone, regardless of gender identity or expression or sexual orientation, can contract HIV. 

Temple, Burdo and Kamel Khalili, chair of the department of microbiology, immunology, and inflammation and a cofounder of Excision BioTherapeutics, are shareholders in Excision BioTherapeutics. This means they must follow university ethics and conflict of interest guidelines, including being transparent about their connection to Excision BioTherapeutics on all published documents related to the treatment or trial, Khalili said.  

Hackett said their HIV diagnosis was both a curse and a blessing because it taught them how to persevere through infections, side effects and mental hardships. Hackett is looking forward to seeing the results of the clinical trial. 

“I have HIV but HIV does not have me,” Hackett said.

Correction: A previous version of this story incorrectly stated the amount of time someone needed to be taking antiretroviral therapy to participate in the clinical trial. It has now been corrected.

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