A group of medical researchers in Maryland believe the answer for curing HIV/AIDS may be gene therapy.
American Gene Technologies (AGT), a Rockville-based medical research company, has submitted an Investigational New Drug (IND) application with the FDA to begin gene therapy trials that researchers believe could eliminate HIV in people already living with the virus.
The drug—an HIV treatment program called AGT103-T—is a single-dose, lentiviral vector-based gene therapy that AGT says could remove infected cells from the body and decrease or eliminate the need for lifelong antiretroviral treatment in HIV-positive patients.
If approved, the company hopes to begin a Phase 1 clinical trial that will examine the safety of AGT103-T in humans.
In a press statement, AGT chief science officer C. David Pauza, PhD, said the company's objective is "to treat HIV disease with an innovative cell and gene therapy that reconstitutes immunity to HIV and will control virus growth in the absence of antiretroviral drugs."
AGT's approach differs from other medical researchers' attempts to cure HIV. As NewNowNext reported earlier this year, researchers in Europe made headlines when two separate HIV-positive patients no longer had the virus after obtaining bone marrow transplants from donors with an HIV-resistant mutation to treat unrelated cancers.
Those patients marked the second and third time doctors were able to effectively "cure" patients living with HIV via bone marrow transplant in the history of modern medicine. However, HIV/AIDS activists and medical professionals were quick to raise concerns about the feasibility of curing HIV with bone marrow transplants on a more widespread basis.
Kenneth Freedberg, MD, a professor of medicine at Harvard Medical School and Massachusetts General Hospital, told NewNowNext in March that the method "is not a remotely plausible strategy for HIV treatment" for the vast majority of patients.
"A bone marrow transplant is an extraordinarily toxic and life-threatening intervention, which you do if someone has an illness that’s clearly going to be fatal," Freedberg explained. "There must be no other treatment options available. It puts people at massive risk for infections and toxicity complications."
As the fight against HIV/AIDS wages on, communities at risk of contracting the virus continue to take preventative measures against new infections—including daily use of Pre-exposure prophylaxis (PrEP), a potentially life-saving HIV prevention drug that is massively popular among gay, bisexual, and queer men.
In the United States, PrEP is pretty much exclusively available as Truvada, its brand-name version manufactured by Gilead Sciences with a very high retail markup. That may change soon, though: Earlier this week, the government filed a lawsuit against Gilead alleging patent infringement on PrEP, which was patented by public health researchers at the Department of Health and Human Services years ago.