WHI Makes History: Involvement in HIV Clinical Trials

Washington Health Institute (WHI) made history on May 19, 2021, by infusing the first patient with what could be a functional cure for HIV. Dr. Jose Bordon, WHI CEO and founding chair and a board certified internal medicine and infectious disease physician, infused Patient 1 of Phase 1 clinical trial with cell and gene therapy product, AGT103-T. The product was developed by the biotechnology company, American Gene Technologies (AGT) based in Montgomery County, Maryland.

AGT received FDA approval last year for this trial which requires a blood draw from the HIV-positive patient to remove HIV-infected white T-cells from their body. The cells are modified by AGT using their cell and gene therapy product, AGT103-T. These modifications make the T-cells impermeable to HIV. 

After 73 days, these modified T-cells were infused back into the patients. According to AGT CEO Jeff Galvin, “It was about 15 minutes to infuse about 100 milliliters that contains 1 billion HIV-specific T-cells that are immune to HIV and then after that, because now the drug is in their body, essentially their cells, those modified cells are the drug, they sit for four hours of observation.”

Dr. Bordon reported on the experience stating, “No side effects. No complications and even more, the patient was smiling and happy and the same, our team was very excited to have this experience.” After seven days, the patient still hadn’t seen any issues from the infusion of modified T-cells. “We were monitoring whether the patient has any complications. Any complaints, but we haven’t seen any,” said Bordon. 

In-human studies give a good indication of the efficacy of the treatment since the patients are infected with the disease the infusion is treating. Participants treated with this cell and gene therapy will be followed for six months in the safety study. They will then be enrolled in an FDA-mandated 15-year long follow-up, which is required for all gene therapy trials.

Treatment with AGT103-T has great potential for finding a functional cure for HIV. A functional cure means that even if it doesn’t completely remove HIV from a person’s body, it won’t matter because it will affect the person as if it did. Even if AGT103-T isn’t the final for HIV, its efficacy can allow tweaking by the company to determine just the right cell and gene therapy.

Galvin stated, “Keep your fingers crossed. If the theory holds and we’ve hit the right numbers on this thing, we believe that this is a great shot on goal for a potential HIV functional cure.” As Dr. Bordon said, “This is the beginning, the beginning of a very long journey, but the beginning is one step and this is one step forward.”

Watch Interview with Dr. Jose Borden of Washington Health Institute

Watch the WJLA News7 story

Watch the Interview with American Gene Technologies CEO Jeff Galvin regarding the in-human trial of AGT103-T




Hinton, Justin. “Maryland-based company hits ‘huge milestone’ in development of ‘HIV functional cure’.” 26 May 2021. https://wjla.com/news/local/maryland-based-company-hits-huge-milestone-in-development-of-hiv-funtional-cure