FDA Approves Human Trials For Treatment to Cure HIV

A Maryland-based company called American Gene Technologies has been cleared to begin human trials on a therapy they say could

A Maryland-based company called American Gene Technologies has been cleared to begin human trials on a therapy they say could offer the cure to HIV. The Rockville, MD, company said this week that they were cleared and are ready to move forward with the cell modification treatment. 

What is HIV?

HIV, the human immunodeficiency virus, is a virus that attacks the T cells of the immune system. History reports, “The virus is transmitted through bodily fluids such as blood, semen, vaginal fluids, anal fluids, and breast milk. Historically, HIV has most often been spread through unprotected sex, the sharing of needles for drug use, and through birth.

Over time, HIV can destroy so many CD4 cells that the body can’t fight infections and diseases, eventually leading to the most severe form of an HIV infection: acquired immunodeficiency syndrome, or AIDS. A person with AIDS is very vulnerable to cancer and to life-threatening infections, such as pneumonia.

Though there is no cure for HIV or AIDS, a person with HIV who receives treatment early can live nearly as long as someone without the virus.”

What are the symptoms of both HIV and AIDS?

According to HIV.gov, symptoms of HIV include flu-like symptoms. “If you have HIV and you are not on HIV treatment, eventually the virus will weaken your body’s immune system and you will progress to AIDS (acquired immunodeficiency syndrome). This is the late stage of HIV infection.

Symptoms of AIDS can include:

  • Rapid weight loss
  • Recurring fever or profuse night sweats
  • Extreme and unexplained tiredness
  • Prolonged swelling of the lymph glands in the armpits, groin, or neck
  • Diarrhea that lasts for more than a week
  • Sores of the mouth, anus, or genitals
  • Pneumonia
  • Red, brown, pink, or purplish blotches on or under the skin or inside the mouth, nose, or eyelids
  • Memory loss, depression, and other neurologic disorders.”

AIDS makes you vulnerable to infection and has an untreated mortality rate of approximately 78%. This is why researchers have worked so hard to find an effective treatment for the disease.

HIV originally appeared in the Democratic Republic of Congo

The first known transmission to humans occurred in 1920 in The Democratic Republic of Congo. It is believed that simian immunodeficiency virus, specifically the strain SIVcpz, a virus affecting chimpanzees, mutated and transferred to humans through bodily fluids as hunters got infected blood on open cuts and wounds, or when they ate the infected chimpanzees. 

It spread locally along roads for decades, before arriving in Haiti and the Caribbean in the 1960’s, and New York in the 1970’s. By 1980, the virus had made it’s way across the US, and international travel brought it elsewhere around the world. 

Once it arrived in the US, HIV highlighted the inequities affecting marginalized communities

Initially in the United States, HIV wasn’t given the attention it deserved. It was seen as, “the gay virus,” and the already-marginalized LGBTQ community struggled to cope with medical discrimination as many doctors and health professionals refused to treat those infected with and suffering from HIV, and it’s evolved partner, AIDS. This perception of the disease as being sexuality-dependent arose from the fact that the first medical articles published by the CDC about the virus centered on the infections of 5 gay men. History reports, “In 1981, the Centers for Disease Control and Prevention (CDC) published a report about five previously healthy homosexual men becoming infected with Pneumocystis pneumonia, which is caused by the normally harmless fungus Pneumocystis jirovecii. This type of pneumonia, the CDC noted, almost never affects people with uncompromised immune systems.

The following year, The New York Times published an alarming article about the new immune system disorder, which, by that time, had affected 335 people, killing 136 of them. Because the disease appeared to affect mostly homosexual men, officials initially called it gay-related immune deficiency, or GRID.

Though the CDC discovered all major routes of the disease’s transmission—as well as that female partners of AIDS-positive men could be infected—in 1983, the public considered AIDS a gay disease. It was even called the ‘gay plague’ for many years after. In September of 1982, the CDC used the term AIDS to describe the disease for the first time. By the end of the year, AIDS cases were also reported in a number of European countries.”

Because the LGBTQ community was less likely to be taken seriously by medical professionals, they were unfairly burdened by the virus in the early years of US spread. But it was spreading in other communities too. The media only talked about, the,“four-H club”:

  • “hemophiliacs, who received contaminated blood transfusions
  • homosexual men, who reported higher incidences of the disease
  • heroin users, and people who used drugs via injection
  • Haitians or people of Haitian origin, many cases of AIDS were reported in Haiti.”

But while they were focused on those populations, it was insidiously spreading elsewhere, even though members of the dreaded Four-H Club were being unfairly blamed. By the late 80’s it was realized that everyone was susceptible to the virus, and they were able to pin-point the spread as occurring through contact with infected bodily fluids. 

Treatments were developed aimed at slowing the virus’s replication within the body

It was thought that if you could keep HIV from advancing to AIDS, you could prevent early death, and treatments developed over the following decades allowed those with HIV to begin leading lives approximately as long as their non-infected peers. In 1987, the first treatment for HIV was released. Azidothymidine, also called AZT, was a nucleoside reverse transcriptase inhibitor (NRTI) given to patients to slow the replication of the HIV virus and attempt to halt it’s progression into AIDS. In 1997, highly active antiretroviral therapy (HAART) was introduced and cut the death rate in patients by a whopping 47%. 

As of now, treatment is usually given in the form of Combivir, which is a combination medicine that improves patient compliance with treatment and outcomes. While it does not cure the virus, it generally slows damage to the body enough to prevent it from progressing to full-blown AIDS, and patients who comply with treatment can often live lives with a span close to what they could have expected without contracting the virus. 

AGT isn’t just talking treatment, they’re talking cure

While advances have been great in the treatment and management of HIV and AIDS, there has thus far been no cure. But AGT says their cell modification therapy may provide just that. The company describes the therapy, AGT103-T, as a genetically-modified product made from a person’s own cells that focuses on repairing damage to the immune system caused by HIV. AGT company chief science officer C. David Pauza says, “Our aim 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.”

If it works, millions of lives could change

If successful, this would affect the lives of the over 38 million people worldwide WHO reported suffer from HIV as of 2018. While great advancements in treatment have been made, a cure would change everything. AGT expects to share preliminary results from their trials late in 2020.